FDA Safety Alerts

4/6/2016
Home Support ISMP
FDASafetyAlerts
Newsletters
Webinars
Report Errors
Educational
Store Consulting
FAQ
Tools
About Us Contact Us
Search
FDA SAFETY ALERTS
FOR DRUGS AND MEDICATION-RELATED MEDICAL DEVICES
DRUGS
AND
THERAPEUTIC BIOLOGICAL PRODUCTS
Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance
(posted 3/9/2016)
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are
produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V.
Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile.
The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of
and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
During FDAs recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise
concerns about I.V. Specialtys ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be
sterile may result in serious and potentially life threatening infections or death.
Health care professionals and consumers should immediately check their medical supplies, quarantine any drug products labeled as sterile from I.V.
Specialty, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they
administer to patients from reliable sources that adhere to proper quality standards.
Morphine Sulfate 0.5 mg/mL Preservative Free (Pharmakon Pharmaceuticals): Recall - Super-potent Product
https://www.ismp.org/tools/fdasafetyalerts.asp
1/166
4/6/2016
FDASafetyAlerts
(posted 2/17/2016)
FDA is alerting healthcare professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe,
CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, in Noblesville, Indiana, because the product is super-potent. Pharmakon
initiated the voluntary recall on February 11, 2016, after receiving laboratory results showing the product was super-potent. On February 16, 2016,
FDA was alerted of serious adverse events in three infants associated with the use of the recalled morphine sulfate products from Pharmakon.
The recalled product was made on February 3, 2016, with an expiration date of March 19, 2016, and labeled with lot E52418EV11C and NDC 451830322-78. The recalled product was distributed to two medical facilities one in Indiana and one in Illinois.
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death.
Health care professionals should immediately check their medical supplies, and quarantine the recalled product from Pharmakon.
Unexpired Sterile Human and Animal Compounded Products by Abbott''s Compounding Pharmacy: Recall - Lack of Sterility Assurance
(posted 1/16/2016)
Abbott''s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility
assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All
recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.
All recalled products have a label that includes the Abbott''s Compounding Pharmacy name and expiration date. If unsure, Customers can call the
pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.
The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott''s Compounding Pharmacy is voluntarily
recalling all sterile compounded products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for
serious and potentially life-threatening infections. To date, Abbott''s Compounding Pharmacy has not received any reports of any adverse effects or
injuries, and the recalled products were distributed exclusively within the state of California directly from its Berkeley, California pharmacy location.
Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product.
Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these
products.
Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container
(posted 1/6/2016)
Hospira, Inc. announced a voluntary recall of one lot of MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50
mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the
2/166
4/6/2016
FDASafetyAlerts
primary bag labeling. The product has a barcode identifying the product contents on both the overwrap and on the primary container. The barcode on
the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for HEPARIN SODIUM 2000
USP UNITS/1000 mL in 0.9% SODIUM CHLORIDE INJECTION. The product is labeled with the correct printed name on the primary container and
overwrap. See the Press Release for product photos.
If the incorrect barcode on Magnesium Sulfate in Water for Injection is not detected prior to dispensing or administration to a patient, and the product
is administered based on the printed name, patient harm is unlikely since the barcode on the overwrap and readable text on the primary container and
overwrap are correct. However, if detected, there is the potential for delay in treatment of Magnesium Sulfate in Water for Injection that can result in
life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise. Administration of
the magnesium sulfate drug product to a patient who is prescribed heparin and in whom the Magnesium Sulfate is contraindicated can result in
serious adverse events related to the drugs pharmacologic action and may require medical intervention. Although serious in nature, the likelihood of
this risk to occur is low due to the high detectability of this nonconformance.
Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. The
product is packaged 50 mL fill, in 100 mL container bags and sold 24 bags per carton (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016). The
lot was distributed nationwide in the U.S. to wholesalers, distributors and hospitals from September 2015 to November 2015. Hospira has initiated an
investigation to determine the root cause and corrective and preventive actions.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should
notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which
may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the
consumer level.
Hospira is notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For
additional assistance, call Stericycle at 1-877-650-7695 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes
Approved
(posted 1/4/2016)
The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in
dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly
substituted for each other but require a change in dose. Direct mg for mg substitution of the two formulations can result in drug levels that are lower
or higher than needed to effectively treat certain fungal infections.
Since the approval of Noxafil delayed-release tablets in November 2013, FDA received eleven reports of the wrong oral formulations being prescribed
and/or dispensed to patients. One case resulted in death, and an additional case resulted in hospitalization. According to the reports, these outcomes
3/166
4/6/2016
FDASafetyAlerts
were a result of health care professionals not knowing that the two oral formulations cannot be substituted for each other without adjusting the dose
due to differences in how the medicine is absorbed and handled by the body.
In addition to changes to the outer carton of Noxafil (see Photos in Drug Safety Communication), its manufacturer Merck revised the prescribing
information and the patient information in the drug label to alert patients and their health care professionals that the two oral formulations of Noxafil
cannot be substituted for each other.
Noxafil is approved in two oral formulations: an oral suspension and a delayed-release tablet. It is also approved as an intravenous solution for
injection. Noxafil is used to help prevent certain invasive fungal infections caused by fungi called Aspergillus and Candida. Noxafil is used in patients
who have an increased chance of getting these infections due to weakened immune systems. Noxafil oral suspension is also used to treat a fungal
infection called thrush caused by Candida in the mouth or throat area.
Prescribers should specify the dosage form, strength, and frequency on all prescriptions they write for Noxafil. Pharmacists should request clarification
from prescribers when the dosage form, strength, or frequency is not specified. Patients should talk to their health care professional before they
switch from one oral formulation to the other. For additional information for health care professionals, patients and caregivers, refer to the Drug Safety
Communication.
Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q Due to Potential Inaccurate Dosage Delivery
(posted 10/28/2015)
Bridgewater, N.J. - Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and
includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which
expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health
consequences, including death because anaphylaxis is a potentially life-threatening condition. As of October 26, 2015, Sanofi has received 26 reports
of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have
described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.
Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of
these reactions. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the United
States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled.
Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter,
fax, email and phone calls and is arranging for return and reimbursement of all recalled products.
Customers with questions regarding this recall can go to www.Auvi-Q.com and call 1-866-726-6340 Monday through Friday 8 a.m. to 8 p.m. ET for
4/166
4/6/2016
FDASafetyAlerts
information about how to return their Auvi-Q devices. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for out of
pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.
Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto-injector. In the event of a
life-threatening allergic reaction (anaphylaxis), patients should only use their Auvi-Q device if another epinephrine auto-injector is not available, and
then call 911 or local medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may
be related to taking or using this drug product.
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
(posted 10/22/2015)
FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalates potential to bind to other medications administered by
mouth drug interactions that could affect how well the other medications work.
The approved labeling for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction
studies with Kayexalate have not been performed. During FDAs review of another potassium-lowering drug, Veltassa (patiromer), we found that
Veltassa bound to about half of the medications tested, some of which are commonly used in patients who require potassium-lowering drugs. Such
binding could decrease the effects of these medications. The label for Veltassa contains a warning not to take other orally administered medications
within 6 hours of taking Veltassa.
Similar to Veltassa, Kayexalate may also bind to other medications administered by mouth. To reduce this potential risk, prescribers and patients
should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours. This includes both prescription
medications, such as antibiotics, blood pressure lowering agents and blood thinners, and those purchased over-the-counter without a prescription,
such as antacids and laxatives. Health care professionals should monitor blood levels or clinical response to the other medications when appropriate.
If the studies conducted by the Kayexalate manufacturer, Concordia Pharmaceuticals, confirm significant interactions with other medications, FDA will
require all manufacturers of sodium polystyrene sulfonate products to update the drug labels to include information about these drug interactions.
Kayexalate (sodium polystyrene sulfonate) and generic brands Kionex and SPS are used to treat hyperkalemia, a serious condition in which the amount
of potassium in the blood is too high. They work by binding potassium in the large intestine so it can be removed from the body.
Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours. Health care
professionals should monitor blood levels or clinical response to the other medications when appropriate. Patients should not stop taking their
potassium-lowering drugs without talking to their health care professional.
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
(posted 10/22/2015)
5/166
4/6/2016
FDASafetyAlerts
FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver
disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications,
Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines,
AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some
of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had
evidence of advanced cirrhosis even before starting treatment with it.
Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to
be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some
of the cases occurred in patients for whom these medicines were contraindicated or not recommended (see the Drug Safety Communication Data
Summary section). FAERS includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.
Viekira Pak and Technivie are used to treat chronic hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and
ritonavir used with or without ribavirin, another hepatitis C medicine. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir,
used in combination with ribavirin.
Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal
hemorrhage, and/or increases in direct bilirubin in the blood.
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea
and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines
without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.
Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors
(posted 9/22/2015)
FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam)
due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels
displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active
ingredients (i.e., 2.5 gram). To prevent medication errors, FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to
ceftazidime 2 gram and avibactam 0.5 gram.
Since Avycazs approval in February 2015, FDA received reports of three medication error cases related to confusion on how the strength was
displayed on the Avycaz vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third
case described concern about the potential for confusion because the strength displayed for Avycaz differs from how the strength is displayed for
6/166
4/6/2016
FDASafetyAlerts
other beta-lactam/beta-lactamase drugs. Based on the information provided in the reports, FDA is aware that at least one of the patients received a
higher-than-intended dose of Avycaz. No adverse events were reported.
Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug
metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options.
Due to reports of medication errors associated with Avycaz, the vial and carton labels have been revised to indicate that each vial contains Avycaz 2.5
gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger
(posted 9/21/2015)
FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or
difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is
evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.
Tramadol is not FDA-approved for use in children; however, data show it is being used off-label in the pediatric population. Health care
professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children.
In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol. Some people have genetic variations that
cause tramadol to be converted to the active form of the opioid faster and more completely than usual. These people, called ultra-rapid metabolizers,
are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing
difficulty that may lead to death. Recently, a 5-year-old child in France experienced severely slowed and difficult breathing requiring emergency
intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils
and adenoids. The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.
Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or
unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents
and caregivers should talk with their childs health care professional if they have any questions or concerns about tramadol or other pain medicines
their child is taking.
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning
(posted 9/8/2015)
FDA is expanding its alert regarding compounded or repackaged drugs stored in Becton-Dickinson (BD) general use syringes to include certain
additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes. See the FDA Alert for links to the BD webpage to
determine which specific lots are affected. FDA continues to investigate this issue and will provide more information when it is available.
7/166
4/6/2016
FDASafetyAlerts
FDAs original alert applied to compounded or repackaged drugs that have been stored in 3 mL and 5mL BD syringes. This expansion of the alert to
include additional sizes of syringes is based on BD reports that an interaction with the rubber stopper in certain lots of these syringes can cause some
drugs stored in these syringes to lose potency if filled and not used immediately. BD reports that the following drugs in particular can be affected by
the stoppers, but FDA does not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone,
atropine, hydromorphone, cisatracurium, and remifentanyl.
Hospital pharmacies and staff should:
Contact any outsourcers to determine if affected lots of BD syringes were used for compounded or repackaged products
Not administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available.
Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns
(posted 8/18/2015)
Hartley Medical is recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns. This recall is a
voluntary measure taken following a recent inspection with issues on Hartley''s sterility methods and testing procedures specifically for this
preparation. Parenteral administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic
infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome.
The affected Prolotherapy with Phenol lots include the following lot numbers and expiration dates:
RX328690 Expires 12/1/2015
RX323132 Expires 10/6/2015
RX321608 Expires 11/1/2015
Prolotherapy with Phenol is used for neurolysis and is packaged in clear 5 mL and/or 100 mL sterile vials with labeling of the pharmacy and the drug.
The product can be identified by its white label on each vial with the name PROLOTHERAPY WITH PHENOL. Product was distributed in California and
Nevada to pain clinics between 5/15/15 7/14/15.
Consumers/distributors/retailers that have affected Prolotherapy with Phenol product should stop using the product and return remaining contents to
the pharmacy.
To return product or request assistance related to this recall, users should call (562) 595-7548, Monday through Friday, from 9:00 a.m. to 5:30 p.m.
PDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using
this drug product.
8/166
4/6/2016
FDASafetyAlerts
Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use
(posted 8/18/2015)
FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and
5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available. Preliminary information indicates that drugs
stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.
If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the
patient has been receiving a subpotent product, or adverse consequences could occur.
BDs 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. The company is alerting their customers not to use these syringes as a
closed container system for compounded and repackaged drugs.
FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only. These syringes were not cleared for use as a
closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established. This issue may
extend to other general use syringes made by other manufacturers that were not cleared for the purpose of closed-container storage usage. FDA has
received several reports of compounded and repackaged drugs, such as fentanyl, morphine, methadone and atropine, losing potency when stored in
BD 3ml and 5ml general purpose syringes. It is possible that this chemical reaction may affect other compounded and repackaged drugs stored in
syringes not FDA cleared for closed-container storage.
Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored
in general purpose BD 3ml and 5ml syringes. These syringes are marked with the BD logo at the base of the syringe. At this time, FDA does not have
information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with
potency or drug degradation when medication is administered promptly after the syringes are filled.
This warning does not extend to products approved by FDA for marketing as pre-filled syringes, because as part of the approval process, FDA has
determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product.
The FDA is continuing to investigate this issue and will provide more information when it is available.
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
(posted 7/31/2015)
Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the
consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the
product.
9/166
4/6/2016
FDASafetyAlerts
The risk associated with mistakenly taking a Clopidogrel tablet instead of a Hydrochlorothiazide tablet is the increased probability of experiencing
Clopidogrel''s side effects which include bleeding and/or bruising. Patients with active bleeding or who are allergic to Clopidogrel or any component of
the formulation may experience more serious adverse health consequences as a result of unknowingly consuming Clopidogrel. Additionally, missing a
dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).
Hydrochlorothiazide tablets are indicated for the management of high blood pressure and edema and are packaged in 1000-count bottles. The
affected Hydrochlorothiazide tablets include Lot # GHYL15028 - Expiration April, 2018, and was distributed nationwide directly to wholesalers,
retailers, and pharmacies from May 21 - 28, 2015. As per Unichem''s internal investigation, this episode is an isolated event noted at one pharmacy
and confined to the recalled lot. Unichem has not received any reports of adverse events related to this recall to date.
Consumers should not consume Hydrochlorothiazide Tablets 25 mg 1000''s from the lot GHYL15028 which is being recalled and should return to
place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to
taking or using this drug product. If the consumer is not sure they received the recalled lot, they should contact the pharmacy that dispensed the
product to them.
Unichem is notifying its distributors and customers by letter, overnight FedEx and emails. Unichem is also arranging for return of all recalled products.
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion
(posted 7/30/2015)
FDA is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting
medication Brilinta have resulted in the wrong medication being prescribed or dispensed. FDA determined that the main reason for the confusion
between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong
medication; however, reports of prescribing and dispensing errors continue.
Brintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder (MDD) in adults. It is in a class of antidepressants
called selective serotonin reuptake inhibitors (SSRIs). Brilinta (ticagrelor) is an antiplatelet, anti-blood clotting medication used to lower the risk of
having another heart attack, or dying from a heart problem after a heart attack or severe chest pain.
Health care professionals can reduce the risk of name confusion by including the generic (established) name of the medication, in addition to the
brand name, and the indication for use when prescribing these medications. Patients should check their prescriptions to ensure that the correct
medication was dispensed. See the FDA Drug Safety Communication for more detailed recommendations.
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance
(posted 7/24/2015)
Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level
due to lack of sterility assurance.The company has not received any reports of product contamination or adverse events to date, and is issuing this
10/166
4/6/2016
FDASafetyAlerts
voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is
contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
The recalled products were made from 7/21/2014 through 7/21/2015, and dispensed to patients or distributed to physicians for further
administering to patients in the states of Arizona, Idaho, Florida, Oregon, Texas, and Washington. All recalled products have a label that includes the
pharmacy name and the name of the compounded drug product. The recall does not pertain to any non-sterile compounded medications prepared by
the pharmacy or to products compounded after July 21, 2015.
For a table of the sterile compounded products subject to the recall, see the Firm Press Release.
The pharmacy has begun notifying its patients by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these
products should immediately discontinue use and return the recalled unexpired products.
To return product or request assistance related to this recall, users should call 509-764-2314, Monday through Friday, from 8:30 a.m. to 12:30 p.m.
and 1 to 5:30 p.m. PDT.; Consumers should contact their physician or health care provider if they have experienced any problems that may be related
to taking these drug products.
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns
(posted 7/16/2015)
FDA is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been
reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or
improved after Proglycem was stopped. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the
Proglycem prescribing information.
FDA identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, the active ingredient in Proglycem, since the drug
was approved in 1973.
Proglycem is usually given in the hospital, and health care professionals should closely monitor babies receiving it, especially those with risk factors
for pulmonary hypertension such as meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia,
sepsis, congenital diaphragmatic hernia, and congenital heart disease. Stop Proglycem treatment if pulmonary hypertension is identified.
Parents and caregivers of any child receiving Proglycem should watch for signs of difficulty breathing such as flaring nostrils, grunting, unusual
movement of their childs chest, rapid breathing, difficulty feeding, or a bluish color of the lips or skin. Immediately alert your childs health care
professionals if you see any of these signs, and talk to them if you have any questions or concerns about Proglycem.
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
11/166
4/6/2016
FDASafetyAlerts
(posted 7/14/2015)
In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10% w/v, packaged in
10 mL prefilled syringes. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. FDA has recently become aware that
some units of this drug may still be on the market. Please check your inventory and crash boxes, quarantine and discontinue distribution and use of
affected lots (see press release below for list of affected lots).
Calcium Chloride Intravenous Infusion 10% w/v is used as part of the resuscitation procedure following a cardiac arrest and for the treatment of low
calcium levels. It is also used for arrhythmias associated with hypocalcaemia, hyperkalaemia or hypomagnesaemia. Because of the use of Calcium
Chloride Intravenous Infusion prefilled syringes in emergency situations, and its use as a lifesaving drug, difficulty in the administration of the drug
could create a potential risk by prohibiting or delaying the administration of the medication.
Immediately examine your inventory and crash boxes, quarantine and discontinue distribution and use of these lots.
If you have the affected product, please contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
In addition, if you have further distributed the affected product, please identify your customers and notify them at once of this market withdrawal. The
customer should be instructed to contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
Additionally, Stericyle will notify your retail level customers that received the affected lots. Provide a list of customers via Microsoft Excel file to
mylan5322@stericycle.com within 10 business days.
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects
(posted 7/1/2015)
FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for
serious side effects, including slowed or difficult breathing.
Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against
using codeine in children who recently had surgery to remove their tonsils and/or adenoids.
In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and
that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma
and other chronic breathing problems.
FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be
12/166
4/6/2016
FDASafetyAlerts
communicated when the FDA review is complete.

Codeine is a specific type of narcotic medicine called an opioid that is used to treat mild to moderate pain and also to reduce coughing. It is usually
combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines.
Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child
should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and
caregivers should always read the product label to find out if a medicine contains codeine and talk with their childs health care professional or a
pharmacist if they have any questions or concerns. Health care professionals should continue to follow the recommendations in the drug labels and
use caution when prescribing or recommending codeine-containing cough-and-cold medicines to children.
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors
(posted 5/20/2015)
The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa
(ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling. (See the Drug Safety Communication
for Label Photos).
FDA evaluated seven reported cases of medication error that occurred during preparation of the dose in the pharmacy due to confusion with the
display of the strength of individual ingredients on Zerbaxas vial labels and carton labeling. Listing the individual drug strengths led to confusion
because it was different from labeling for other drugs in the beta-lactam/beta-lactamase class that express strength as the sum of the two active
ingredients. In some cases, this led to administration of 50% more drug than was prescribed. No adverse events were reported among these seven
cases.
Zerbaxa is used to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated
infections in the abdomen. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness.
FDA urges health care professionals and patients to report side effects and medication errors involving Zerbaxa to the FDA''s MedWatch Safety
Information and Adverse Event Reporting Program:
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
(posted 5/15/2015)
FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where
the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will
determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2)
inhibitors.
13/166
4/6/2016
FDASafetyAlerts
SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2
diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2
inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin.
Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as
difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines
without first talking to your prescriber.
Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms;
discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels. See the FDA
Drug Safety Communication for more information.
Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
(posted 4/24/2015)
Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 04091162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free
floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both
human and veterinary).
Risk factors associated with particulate include the potential for particulate to be injected and/or therapy may be delayed. If smaller pieces of the
particulate break off and become free floating within the solution, it may be injected into the patient. Injected particulate may result in local
inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue, in particular in patients allergic or
sensitive to iron oxide. In addition, therapy may be delayed if observation of particulate is not made until the point of care. This delay is likely to be of
negligible clinical significance provided remediation is readily available.
The lot was distributed from July 2014 to September 2014. Hospira is currently working with its glass supplier and has initiated an investigation to
determine the root cause and corrective and preventive actions.
Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers should
user level (both human and veterinary). Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be
returned to Stericycle. For additional assistance, call Stericycle at 1-866-918-8770 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
14/166
4/6/2016
FDASafetyAlerts
Mucinex Fast-MAX Products: Recall - Incorrect Labeling

(posted 4/22/2015)
RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus;
Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat because the over-the-counter medications, which
correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the
back. This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product
ingredients which include acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention,
particularly in the case of acetaminophen use in people with liver impairment.
RB is notifying its distributors and customers by direct correspondence. See the press release for a listing of affected product lot numbers.
RB is asking consumers to responsibly dispose of any unused product in accordance with the following recommended guidance for drug disposal in
your household trash:
Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag; and
Throw the container in your household trash.
Consumers who have purchased this product can also contact the RB MUCINEX FAST-MAX recall toll free number at 1-888-943-4215 between the
hours of 8:00 a.m.- 8:00 p.m eastern standard time with any questions or to speak with a representative, and should refer to www.mucinex.com/recall
for the accurate related drug facts information. Consumers should contact their physician or healthcare provider if they have experienced any
problems that may be related to taking or using this drug product.
Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter
(posted 4/10/2015)
Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of
particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent
and severity of harm depends on the size, number, and composition of the foreign material, and patients underlying medical condition. In the absence
of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and
systemic embolization. In high-risk patients this may lead to serious adverse health consequences.
The lots being recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015.
15/166
4/6/2016
FDASafetyAlerts
See the press release for a listing of affected products.

While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a
solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter. Baxter
began the customer notification process on March 24, 2015.
Customers have been directed not to use products from the recalled lots. Recalled products should be returned to Baxter for credit by contacting
Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time.
Unaffected lots of product are available for replacement.
Feraheme (ferumoxytol): Drug Safety Communication Warnings Strengthened and Prescribing Instructions Changed
(posted 3/31/2015)
FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). FDA
changed the prescribing instructions and approved a Boxed Warning, FDAs strongest type of warning, regarding these serious risks. Also added is a
new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron
replacement product.
All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of Ferahemes approval in 2009, this risk was described in
the Warnings and Precautions section of the drug label. Since then, serious reactions, including deaths, have occurred despite the proper use of
therapies to treat these reactions and emergency resuscitation measures (see Drug Safety Communication/Data Summary). FDA evaluated this risk
further and has identified ways to reduce the risk of serious allergic reactions with Feraheme.
FDA is continuing to monitor and evaluate the risk of serious allergic reactions with all IV iron products, and we will update the public as new
information becomes available.
Feraheme is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemiaa condition in which there is a
lower than normal number of oxygen-carrying red blood cells because of too little iron. Feraheme is specifically approved for use only in adults with
iron deficiency anemia in patients with chronic kidney disease.
Based on FDAs evaluation, the prescribing instructions and other label information were updated, adding a Boxed Warning that describes these serious
risks and recommending that health care professionals:
Only administer IV iron products to patients who require IV iron therapy.
Do not administer Feraheme to patients with a history of allergic reaction to Feraheme or other IV iron products.
16/166
4/6/2016
FDASafetyAlerts
Only administer diluted Feraheme as an IV infusion over a minimum of 15 minutes. Feraheme should not be given as an undiluted IV injection.
Closely monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during Feraheme
administration and for at least 30 minutes following each infusion.
Carefully consider the potential risks and benefits of Feraheme administration in elderly patients with multiple or serious medical conditions, as these
patients may experience more severe reactions.
Carefully consider the potential risks and benefits of Feraheme administration in patients with a history of multiple drug allergies. Patients with
multiple drug allergies may also be at higher risk.
Lactated Ringer''s Irrigation, 3000mL by Hospira: Recall - Mold Contamination
(posted 3/12/2015)
Hospira initiated a voluntary recall of one lot of Lactated Ringer''s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the
user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the
primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis.
If contaminated solution is used on a patient it may cause bacteremia, sepsis, septic shock and endocarditis, and death may result. Signs and
symptoms may include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting. Septicemia could lead to
shock and multi-system organ failure, requiring critical medical intervention. The mold is considered allergenic and exposure to it may induce an
allergic response or immune response to the particulate including anaphylaxis. Delayed therapy may occur if the particulate were to block the flow of
the solution during irrigation.
Lactated Ringers Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection, intended only for sterile irrigation, washing and
rinsing purposes. The product is packaged in 3000 mL flexible container bags and sold four bags per carton (NDC: 0409-7828-08, Lot 40-008-JT,
Expiry 1APR2016). The lot was distributed nationwide in the United States to wholesalers, distributors, surgery centers, and hospitals from June 2014
through September 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers should
user level (both human and veterinary). Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be
returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-877-907-7037 between the hours of 8 am to 5 pm ET,
Monday through Friday.
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and
17/166
4/6/2016
FDASafetyAlerts
Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-St

(posted 3/10/2015)
FDA is warning health care professionals not to use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices
(CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs contain either polycarbonate
or ABS and are not compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution).
N, N-dimethylacetamide (DMA), an ingredient in Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), is incompatible with polycarbonate or
ABS. Devices that contain polycarbonate or ABS dissolve when coming into contact with DMA. This can lead to device failure, possible product
contamination, and potential serious adverse health consequences, including skin reactions in health care professionals preparing and administering
this product and the risk of small blood vessel blockage in patients.
FDA is requiring label changes for both the solution and the powder formulations of Treanda to reflect safe preparation information.
Treanda is available in two formulations, a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution); and a lyophilized powder, Treanda
for Injection (25mg/vial or 100 mg/vial lyophilized powder). Closed system transfer devices are devices that are used to prepare and administer
hazardous drugs for intravenous infusion, such as chemotherapy drugs.
RECOMMENDATION: Health care professionals should stop using Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with CSTDs or vial
adapters and syringes containing polycarbonate or ABS. If using Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution):
If a CSTD would be used with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mLsolution), FDA advises health care professionals to verify with the
CSTD manufacturer or Teva U.S. Medical Information (1-800-896-5855) that the CSTD is compatible with Treanda Injection (45 mg/0.5 mL or 180
mg/2 mL solution) prior to preparing the drug.
FDA recommends health care professionals only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer
Treanda Injection. Polypropylene syringes are translucent in appearance.
Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) should be inspected visually for particulate matter and discoloration prior to
administration whenever solution and container permit.
Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) must be withdrawn and transferred for dilution in a biosafety cabinet (BSC) or containment
isolator and withdrawn and transferred using a polypropylene syringe with a metal needle and a polypropylene hub.
If using Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder):
18/166
4/6/2016
FDASafetyAlerts
Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder), must be reconstituted. If a
CTSD or adaptor is to be used as supplemental protection during preparation, only use Treanda for Injection (25mg/vial or 100 mg/vial lyophilized
powder) and not the solution formulation.
Do not mix or combine the solution and lyophilized powder formulations of Treanda.
Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling
(posted 3/6/2015)
Hospira announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT,
Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the
overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP
units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap.
If the incorrect barcode on Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/ mL is not detected prior to dispensing or administration to a patient,
and the product is administered based on the printed name, patient harm is unlikely since the barcode on the overwrap and readable text on the
primary container and overwrap are correct. However, if detected, there is the potential for delay in treatment of magnesium sulfate in 5% dextrose,
that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Administration of the magnesium sulfate drug product to a patient who is prescribed heparin and in whom the magnesium sulfate is contraindicated
can result in serious adverse events related to the drugs pharmacologic action and may require medical intervention.
Magnesium sulfate in 5% dextrose injection, USP, is a prescription product administered intravenously for the prevention and control of seizures in
preeclampsia and eclampsia, respectively. The product is packaged in 50/100 mL container bags and sold 24 bags per carton (NDC: 0409-6727-23,
Lot 42-120-JT, Expiry 1DEC2015). The lot was distributed nationwide in the U.S. to wholesalers, distributers and hospitals from October 2014 to
January 2015.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should
consumer level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the
United States. For additional assistance, call Stericycle at 1-866-382-9260 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. Patients
should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility
(posted 2/24/2015)
19/166
4/6/2016
FDASafetyAlerts
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials
(NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by
Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and
100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting
product sterility.
Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who
are immunocompromised.
The lot numbers being recalled are VATA012, VATA015 (50mg/5mL) and VATB012, VATB013, VATB014, VATB017 (100mg/10mL) which were
distributed to hospitals, wholesalers and distributors nationwide from February 2014 through February 2015 and are supplied in single-dose and
multi-dose vials.
Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by
the recall.
Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product.
Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product
recall. The necessary form by which to document this information as well as other information regarding this recall is available at
www.Sagentpharma.com.
Simulated IV Solutions from Wallcur: CDER Statement- FDA''s Investigation into Patients being Injected
(posted 1/14/2015)
FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcurs simulated intravenous (IV)
saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. So far, more than 40
patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including
fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products; it is not known
if this death is directly related to the use of the product.
Wallcurs simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities
in numerous states. While Sodium Chloride 0.9% Injection (IV normal saline) has been in tight supply, FDA has been working with manufacturers to
increase supply. In addition, FDA is not objecting to the temporary distribution of additional IV normal saline from alternate sources Fresenius Kabi
USA, Baxter Healthcare Corp., and B. Braun Medical Inc. Currently, there is supply available from several manufacturers as posted on FDAs website.
Healthcare Providers
20/166
4/6/2016
FDASafetyAlerts
Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the
possible injection of Wallcur simulated products into patients.
Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled Wallcur, Practi-products, For clinical simulation, or Not for
use in human or animal patients.
If you have products labeled with any of these words, or you suspect you may have received other products intended for training purposes, separate
simulation products from existing inventory and contact your distributor for directions on how to return these products.
If you have received Wallcur Practi-products by mistake, please contact the distributor, or Wallcur, LLC of San Diego for return instructions.
Consider reviewing your office procedures and make sure there are procedures in place to visually inspect all future shipments of normal saline
products to ensure they are for clinical use.
If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse
event:
Evaluate all potentially exposed patients with new, or ongoing symptoms;
Use appropriate treatment;
Report suspected cases to the state health department; and
Report any adverse events following use of these products to FDAs MedWatch program online or at 1-800-332-1088.
Patients
Patients who believe they received an injection of Wallcur simulated IV solution should contact their health care provider.
Patients who received simulated IV saline almost immediately upon injection experienced fever, chills, muscle aches, headaches, and some required
hospitalization. In most reported cases, these signs and symptoms were immediately recognized and patients received appropriate medical attention.
You may also file a report of the incident through FDAs MedWatch program, and assist the FDA with this ongoing investigation.
If you know you will be receiving normal saline, ask your doctor or nurse to visually inspect the bag, and ensure they are using normal saline for
human use. Ensure the bag is not labeled or printed with any of the following: Wallcur, Practi-products, For clinical simulation or Not for use in
human or animal patients. If the saline bag contains any of these words, ask your health care provider NOT to administer the solution.
Wholesalers, Distributors, Suppliers
21/166
4/6/2016
FDASafetyAlerts
Inspect your inventory and ensure you are not distributing simulated products as clinical use products.
It is incumbent upon wholesalers, distributors, and suppliers to clearly and accurately label and distribute their products to prevent medical product
mix-ups from occurring.
If you suspect you may have distributed this product to clients by mistake, immediately attempt to recall the products and warn clients of the potential
risks. You should also contact Wallcur, your distributor and file a report to FDAs MedWatch program.
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
(posted 12/30/2014)
The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or
animal patients. These products are for training purposes only. There have been reports of serious adverse events associated with the use of certain of
these products i.e., Practi IV Solution Bags.
FDA has become aware that some Wallcur training IV products have been distributed to health care facilities and administered to patients. FDA will
continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform health care
professionals and state health departments.
Before administering IV solutions to patients, health care providers should carefully check the labels to ensure that the products are not training
products, such as Practi IV Solution Bags marketed by Wallcur. Wallcurs training products, which may bear the words for clinical simulation, are not
to be administered to patients.
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter
(posted 12/11/2014)
Baxter International Inc. announced today it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100
mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter
that was identified as a fragment of the frangible from the vial adapter. The issue was identified upon standard visual inspection prior to patient
administration.
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of
harm depends on the size, number, and composition of the foreign material, and the patient''s underlying medical condition. In the absence of in-line
filtration, particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic
embolization (blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver). There have
been no reported adverse events for the affected lots.
22/166
4/6/2016
FDASafetyAlerts
0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container is a sterile, nonpyrogenic solution for intravenous administration after
admixture with a single dose powdered drug. This recall affects the following lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS
Container:
Product Code NDC Number Lot # Expiration Date
2B0043 0338-0553-18 P317842 May 2015
2B0043 0338-0553-18 P317891 May 2015
Unaffected lot numbers can continue to be used according to the instructions for use.
According to the 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container product labeling, the product should be inspected visually
for particulate matter and discoloration whenever solution and container permit.
Baxter has notified customers, who are being directed not to use product from the recalled lots. Recalled product should be returned to Baxter for
credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m.,
Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00
p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have
experienced any problems that may be related to using this drug product.
Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported
(posted 11/25/2014)
FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain
infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the
immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the
Tecfidera drug label.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but
can cause PML in some patients who have weakened immune systems.
See the FDA Drug Safety Communication for additional clinical information about this case.
Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS), a brain and spinal cord disease in which patients experience multiple
episodes of weakness, numbness, and other nervous system signs and symptoms that partially or completely resolve overs weeks or months. Patients
23/166
4/6/2016
FDASafetyAlerts
may develop persistent symptoms and disability over time.

Healthcare professionals should:
Tell patients taking Tecfidera to contact you if they develop any symptoms that may be suggestive of progressive multifocal leukoencephalopathy
(PML). Symptoms of PML are diverse, progress over days to weeks, and include the following: progressive weakness on one side of the body or
clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation, leading to confusion and personality changes. The
progression of deficits can lead to severe disability or death.
Stop Tecfidera immediately at the first sign or symptom suggestive of PML and perform an appropriate diagnostic evaluation.
Monitor lymphocyte counts in Tecfidera-treated patients according to approved labeling.
Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch
(posted 11/21/2014)
Baxter International Inc. voluntarily recalled one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a
complaint of mislabeling of the overpouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per
100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium
Chloride Injection, 20 mEq per 100 mL.
The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the high-risk
patient population patients prone to severe electrolyte imbalance this hazardous situation may lead to serious, life-threatening adverse health
consequences. There have been no reported adverse events associated with this issue to date.
Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Products were distributed to customers in the
U.S. between June 23, 2014 and October 2, 2014.
Baxter has notified customers, who are being directed not to use product from the recalled lot. Recalled product should be returned to Baxter for
credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m.,
Central Time. Unaffected lot numbers can continue to be used according to the instructions for use. Unaffected lots of product are available for
replacement. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this
drug product.
Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling
(posted 9/17/2014)
24/166
4/6/2016
FDASafetyAlerts
Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot #
P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a
single lot. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80
mg in 100 mL, product code 2B0862.
As both products are packaged in 100mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of
medication error or delay in therapy for patients that require high concentration potassium chloride.
The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014. There
have been no reported adverse events associated with this situation to date.
Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin Sulfate is an antibacterial drug for
intravenous administration.
It is recommended that healthcare professionals carefully review the product label before administering.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00
p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have
experienced any problems that may be related to using this drug product.
Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging
(posted 7/21/2014)
American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit
dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily
recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This recall is the result of mislabeled inner unit dose blister
packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. Failure to receive the proper dose of
oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of
patients in which use of ibuprofen is contraindicated
Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy.
Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and
individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by physical description: white,
oval-shaped, film-coated tablets, with IP 465 printed on one side.
Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and
25/166
4/6/2016
FDASafetyAlerts
individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by physical description: yellow
color, capsule shaped, film-coated tablets scored and debossed with ''184'' on one side and scored on other side.
These hospital unit dose products were distributed nationwide beginning June 20, 2014
Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.
Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608
from 7am to 5pm CST for instructions on returning the recalled product.
For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact
American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST.
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance
(posted 7/19/2014)
FDA is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision
Pharmacy, in Dallas, as they may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and
potentially life-threatening infections or death.
FDA investigators inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products
produced by the company, which puts patients at risk (Form FDA-483 issued July 16, 2014). The inspection revealed sterility failures in 19 lots of drug
products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. Endotoxins are
substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other
circulatory functions.
NuVisions products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer
them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance
(posted 7/11/2014)
The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs
marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. To date,
26/166
4/6/2016
FDASafetyAlerts
FDA is not aware of reports of illness associated with the use of these products.
Unique Pharmaceuticals products were distributed nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.
FDA investigators conducted two recent inspections of the Unique Pharmaceuticals facility and observed insanitary conditions that result in a lack of
sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483s issued April 4, 2014
(PDF - 4.28MB), and June 20, 2014 (PDF - 1MB)). These inspections revealed sterility failures in several lots of drug products intended to be sterile,
recurring environmental contamination problems, and poor sterile production practices.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not
administer them to patients. Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their
health care professional. The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of
any Unique Pharmaceuticals products to the FDAs MedWatch Adverse Event Reporting program:
Hospira Lactated Ringer''s And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
(posted 7/11/2014)
Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL,
Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015 . This action is due to one confirmed customer report where particulate
was identified within the solution of the primary container. The particulate was identified as a filamentous-like structured particulate indicative of
mold. Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak.
Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization
or organ failure. Hospira has not received reports of any adverse events associated with this issue for this lot to date, and has not identified any quality
issues with retention samples for this lot.
The product is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as
required by the clinical condition of the patient. The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12
overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container. This lot was distributed
nationwide from December 2013 through February 2014 and was distributed to hospitals, clinics, wholesalers and distributors.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457
between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product.
Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain
(posted 6/26/2014)
27/166
4/6/2016
FDASafetyAlerts
FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should
not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to
highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause
serious harm, including death.
Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the babys mouth
within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in
seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and
children being hospitalized or dying.
In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who
were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental
ingestions. See further details in the FDA Drug Safety Communication.
Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American
Academy of Pediatrics recommendations for treating teething pain.
Use a teething ring chilled in the refrigerator (not frozen).
Gently rub or massage the childs gums with your finger to relieve the symptoms.
FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because
some of them can be harmful. FDA recommends following the American Academy of Pediatrics recommendations to help lessen teething pain.
Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks
(posted 6/13/2014)
FDA is warning consumers not to purchase or to use Thorne Researchs Captomer or Captomer-250, marketed as a dietary supplement for heavy
metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is
contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children. FDA advises consumers to avoid all
products offered over-the-counter (OTC) for chelation or detoxification. There are no FDA-approved OTC chelation products.
Procedures involving chelation agents carry significant risks and should be performed only under medical supervision.
The company has received several adverse event reports associated with these products. Thorne Research has agreed to voluntarily recall the products.
For recall information, contact Thorne Research.
28/166
4/6/2016
FDASafetyAlerts
FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron
overload.
Do not purchase or use Captomer or Captomer-250. Avoid all products offered over-the-counter (OTC) for chelation or detoxification.
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
(posted 6/11/2014)
Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots
manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMBBA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is
recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+blood glucose test strips with the Taidoc
meters listed in the Firm Press Release, which could result in incorrect glucose results.
Falsely high or falsely low glucose results could potentially cause missed or delayed hyperglycemia or hypoglycemia detection and lead to no treatment
or inappropriate treatment. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states could lead to serious health consequences,
including death.
Diabetic Supply of Suncoast, Inc. is notifying its wholesale Distributors, Pharmacies, Medical Supply stores, Health Care Providers and direct customers
throughout the entire US and Virgin Islands by letter and Press Release about the specifics of the recall.
Customers who have the affected test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information. Test strips will be replaced
with relabeled boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned test strips and contact
Suncoast to find out if this recall pertains to the test strips they have in their possession and if so how to have them replaced for the relabeled
products manufactured by BroadMaster Bio-Tech.
Customers with questions may contact Diabetic Supply of Suncoast at (561) 296-0488 between the hours of 9:00AM and 5:00PM Monday through
Friday Eastern standard time or view the information at www.dsosi.com.
Customers who have the Advocate Redi-Code blood glucose meters manufactured by Taidoc Technology Corp should follow the product User Manual
for information about the appropriate test strips to be used with the Taidoc meters.
Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment
(posted 5/15/2014)
FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause
next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime.
29/166
4/6/2016
FDASafetyAlerts
Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. FDA approved
changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic
eszopiclone products will also be updated to include these changes.
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can
last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware
they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their
prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them. FDA is continuing to evaluate
the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and
will update the public as new information becomes available.
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
(posted 5/13/2014)
The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in
the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000
Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clotrelated strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of
Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.
Importantly, the new study is based on a much larger and older patient population than those used in FDAs earlier review of post-market data, and
employed a more sophisticated analytical method to capture and analyze the events of concern. This studys findings, except with regard to MI, are
consistent with the clinical trial results that provided the basis for Pradaxas approval. As a result of these latest findings, the FDA still considers
Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.
Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called nonvalvular atrial fibrillation (AF).
Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning
medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals who
prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.
Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension
(posted 3/31/2014)
30/166
4/6/2016
FDASafetyAlerts
FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH).
Revatio is FDA-approved only to treat PAH in adults, not in children; however, health care professionals must consider whether the benefits of
treatment with the drug are likely to outweigh its potential risks for each patient.
FDA revised the Revatio drug label in August 2012, adding a warning stating that use of Revatio, particularly chronic use, is not recommended in
children. This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in
pediatric patients with PAH. FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio
may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring.
The purpose of the August 2012 recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients
taking a high dose of Revatio when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest that Revatio
should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to
prescribe or administer the drug.
The evidence behind FDAs initial recommendation has not changed; this communication is clarifying the strength of the warning communicated in the
Revatio drug label.
Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible
Presence of Tikosyn Capsules
(posted 3/7/2014)
Pfizer Inc. issued a voluntary recall of one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor
XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release
capsules. This action is being taken because of a pharmacist report that one bottle of Pfizers Effexor XR contained one capsule of Tikosyn (dofetilide)
0.25mg in addition to the Effexor XR capsules.
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been
considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.
This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot
number V130014, which expires in August 2015.
These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such
as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled
products.
Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their
31/166
4/6/2016
FDASafetyAlerts
customers to whom they distributed the products. Patients with affected product should notify their physicians and/or return product to their
pharmacies.
Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with
questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm
ET).
Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients
(posted 3/6/2014)
The FDA has concluded that Doribax (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an
increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name
Primaxin). Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA
approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is
not approved to treat any type of pneumonia.
In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day
treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%;
n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm.
Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop
pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated
intra-abdominal infections and complicated urinary tract infections, including kidney infections (pyelonephritis).
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold
(posted 3/6/2014)
Baxter International notified health professionals and their care organizations of the recall in the United States of a single lot of DIANEAL PD-2
Peritoneal Dialysis Solution with 1.5% Dextrose 6000ml to the hospital/user level. The recall is being initiated as a result of complaints of particulate
matter, identified as mold. The affected lot is C903799, expiration 05/15 (product code L5B9710), NDC 00941-0411-11. Product affected by this
recall was packaged in flexible plastic containers and distributed to dialysis centers, facilities, distributors and patients in the United States between
May 2013 and January 2014.
DIANEAL is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on PD therapy.
Baxter notified customers by recall letter to instruct customers to locate and remove any affected product from their facility. All patients who received
product from the affected lot also were contacted by recall letter and provided instructions to arrange for product return. Dialysis centers, facilities,
32/166
4/6/2016
FDASafetyAlerts
distributors and patients should stop use and return to place of purchase.
As per product labeling, the container should be inspected visually for signs of leakage prior to use. Solutions that are cloudy, discolored, contain
visible particulate matter, or show evidence of leakage should not be used.
Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination
(posted 2/7/2014)
FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz.,
between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations calcium
gluconate injection product. The testing identified gram-positive rod bacteria in the product. A contaminated injectable drug can put patients at risk
of adverse health consequences and possibly a serious infection.
Rx Formulations recalled products marketed as sterile on December 13, 2013.
Health care providers and hospital staff should immediately check their medical supplies, and quarantine the affected products.
Patients who were administered any drug marketed as sterile produced by Rx Formulations between Nov. 7 and Dec. 11, 2013, and who have
concerns, should contact their health care provider.
Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
(posted 1/31/2014)
FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk
and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of
cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information
from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only
for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.
At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not
stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care
professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The
prescribing information in the drug labels of FDA-approved testosterone products should be followed.
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing
and Dispensing
33/166
4/6/2016
FDASafetyAlerts
(posted 1/14/2014)
FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more
than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325
mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of
acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver
transplant, and death.
Cases of severe liver injury with acetaminophen have occurred in patients who:
took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
took more than one acetaminophen-containing product at the same time; or
drank alcohol while taking acetaminophen products.
In January 2011 FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen
to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver
damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient
intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries,
post-operative pain, or pain following dental procedures.
Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as
cough and cold ingredients. FDA will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that
many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.
More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing
more than 325 mg of acetaminophen per dosage unit remain available. In the near future FDA intends to institute proceedings to withdraw approval of
prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.
FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. FDA also
recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that
they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if
appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing
determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription
combination drug product.
Sodium Phosphate Over-the-Counter Products: Possible Harm From Exceeding Recommended Dose
(posted 1/8/2014)
34/166
4/6/2016
FDASafetyAlerts
FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but
serious harm to the kidneys and heart, and even death.
FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose
of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in
death. These serum electrolytes include calcium, sodium, and phosphate. According to the reports, most cases of serious harm occurred with a single
dose of sodium phosphate that was larger than recommended or with more than one dose in a day.
OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. Marketed under the brand-name Fleet, and as
store brands and generic products. Available as single-ingredient drug products, containing either sodium biphosphate or sodium phosphate, and as
combination drug products containing both ingredients.
Consumers and health care professionals should always read the Drug Facts label for OTC sodium phosphate drugs and use these products as
recommended on the label, and not exceed the labeled dose. Caregivers should not give the oral products to children 5 years and younger without
first discussing with a health care professional. Health care professionals should use caution when recommending an oral dose of these products for
children 5 years and younger. The rectal form of these products should never be given to children younger than 2 years.
CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products
(posted 1/6/2014)
Baxter International and FDA notified health professionals and their medical care organizations of a voluntary recall in the United States of two lots of
CLINIMIX and one lot of CLINIMIX E Injection parenteral nutrition products due to complaints of particulate matter found in the products. The affected
product codes are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot P28512, exp 05/14). The affected lots were
distributed to customers between May 2012 and October 2013.
If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the
kidney or liver. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs.
CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are premixed sterile
intravenous (IV) parenteral nutrition products that come in multi-chambered containers and are used as a caloric component and as a protein source
in a parenteral nutrition program.
Baxter has notified customers, who have been directed not to use product from the recalled lots and to locate and remove all affected product from
their facility.
According to the product labeling, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution
and container permit. The use of a final filter is recommended during administration of all parenteral solutions where possible.
35/166
4/6/2016
FDASafetyAlerts
Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance

(posted 12/19/2013)
Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility
assurance. All unexpired lots of sterile compounded products are subject to the recall. Sterile products are injectable medications, IVs, eye drops,
pellet implants, nasal sprays, inhalation solutions, and eye ointments.
The recall was issued after a single, isolated report of an adverse event involving a patient in California who received a compounded medication from
the pharmacy. Out of an abundance of caution, Abrams Royal is voluntarily recalling all sterile products within expiry. If there is microbial
contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
All recalled products have a label that includes Abrams Royal Pharmacys name and phone as well as a lot number. While not every label contains an
expiration date, consumers can call the pharmacy with the lot number and find out the expiration date.
The recalled products were distributed to health care facilities, physicians, and patients from June 17, 2013, through December 17, 2013.
Abrams Royal Pharmacy is notifying its customers by mail and is arranging for the return of all recalled medication. To return product or request
assistance related to this recall, users should contact Abrams Royal at 214-349-8000, Monday through Friday, between 9:00 a.m. and 5:00 p.m. CST.
Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product.
Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions
(posted 12/3/2013)
FDA is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and
death. FDA approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions.
These skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment.
However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of SJS
and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death. See the FDA Drug
Safety Communication for a Data Summary and additional information.
The Onfi drug label has been revised to add information about the risk for serious skin reactions to the Warnings and Precautions section and to the
Medication Guide.
Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called
Lennox-Gastaut Syndrome.
36/166
4/6/2016
FDASafetyAlerts
Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment or when re-introducing
therapy. Health care professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not
drug-related.
Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives.
Patients should not stop taking Onfi without first talking to their health care professionals. Stopping Onfi suddenly can cause serious withdrawal
problems, such as seizures that will not stop, hallucinations, shaking, nervousness, and stomach or muscle cramps.
FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results
(posted 11/28/2013)
Abbott is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the United States. These lots of test strips
may produce erroneously low blood glucose results when used with both "FreeStyle Blood Glucose Meter" and "FreeStyle Flash Blood Glucose Meter
[neither of which have been in production since 2010], as well as the OmniPod Insulin Management System.
When the test strips are used with the newer FreeStyle brand meters including FreeStyle Freedom Blood Glucose Meter, FreeStyle Lite Blood Glucose
Meter and FreeStyle Freedom Lite Blood Glucose Meter, the blood glucose test results are not affected. Testing with the FreeStyle InsuLinx Blood
Glucose Meter is not affected by this action, as FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test strips.
The affected test strips are from lots that hold expiration dates from between May 2014 and March 2015, and can be located in the Firm Press Release.
The company is notifying healthcare professionals, pharmacies, distributors and customers about the recall; customers affected by this action are
instructed to call Abbott''s diabetes care customer service at 1-888- 736-9869 for a replacement of the affected test strips at no charge.
Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates
(posted 11/22/2013)
including Auto-Injectors for
Atropen (atropine)
DuoDote (atropine/pralidoxime chloride)
morphine sulfate
pralidoxime chloride
diazepam
FDA is aware of a disruption in supply to health care providers and emergency response personnel of Atropen (atropine), DuoDote
37/166
4/6/2016
FDASafetyAlerts
(atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors manufactured by Meridian Medical
Technologies, a Pfizer Inc. company. FDA and Meridian are working together to resolve the disruption as quickly as possible, but it is unclear how long
this disruption may persist.
FDA concluded that it was scientifically supported that certain lots of DuoDote can be used for an additional year beyond the manufacturers original
labeled expiration date. FDA is continuing to assess whether these identified lots of DuoDote can receive further expiration date extensions if needed,
and whether additional lots of DuoDote that were not listed in FDAs September 5, 2013, memo can have their expiration date extended.
FDA is currently reviewing data for the potential use of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime
chloride, and diazepam auto-injectors beyond their labeled expiration dates in order to mitigate any potential shortages of these medically necessary
drugs.
FDA will provide additional information about use of these products beyond the labeled expiration date in the coming weeks. Until FDA provides
additional information, these expired auto-injectors may be used for patient care under emergency situations when no other product is available.
Health care providers and emergency response personnel who have any of the auto-injectors manufactured by Meridian identified above that are
nearing or beyond the labeled expiration date should retain the products until FDA is able to provide additional information regarding the continued
use of these products.
Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance
(posted 11/16/2013)
Nature's Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling all lots of sterile products compounded by the pharmacy that are
not expired to the consumer level. The product will be in the form of an injectable drug or an eye drop. The recall is being initiated due to concerns
associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
This recall is being conducted as a result of an inspection conducted by the North Carolina Board of Pharmacy. These products were supplied to the
offices of licensed medical professionals and to patients by prescription within the pharmacy's local market area in North Carolina. They were
distributed from January 1, 2013 to present. Out of abundance of caution and in the interest of the pharmacy's patients, Nature's Pharmacy has
decided to voluntarily proceed with this recall process and to cease production of all sterile products.
Medical professionals, clinics, or patients who have these products should stop its use and return them to the place of purchase. Clinics should contact
any patient that has received treatment using any of these sterile products. Consumers or health care providers with questions regarding this recall
may contact Nature's Pharmacy at 828-251-0094 or toll free at 800-645-8201 Monday through Friday, 9:30 am to 6:00 pm EST or by e-mail:
naturespharmacy@natpharm.biz.
Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease
38/166
4/6/2016
FDASafetyAlerts
Risk of Infection
(posted 11/13/2013)
The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC)
topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from
antiseptic products labeled for preoperative or preinjection skin preparation. When used properly, topical antiseptics are safe and effective products to
reduce the number of bacteria on patients skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when
organisms are introduced into the product by users. Therefore, health care professionals and patients should follow all label directions to decrease the
chances of infection.
Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease
Control and Prevention (CDC). Clinical infections have also been reported to FDA, leading to some product recalls. The reported outcomes ranged from
localized infections at injection sites to systemic infections that resulted in death. FDA has reviewed reports of four deaths, five cases of wound
infection, seven cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site
infection, and 32 cases of bacteremia. These infections have been confirmed to be caused by contaminated antiseptic products. Affected products
included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products.
Organisms implicated in the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans,
Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.
Over-the-counter (OTC) topical antiseptic drugs for use according to the label instructions to reduce the number of bacteria on the skin prior to
surgery or injections. When used properly, over-the-counter (OTC) topical antiseptics are safe and effective products to reduce the number of bacteria
on the skin prior to surgery or an injection. Commonly used products contain isopropyl or ethyl alcohol, povidone iodine, poloxamer iodine,
benzalkonium chloride, benzethonium chloride, or chlorhexidine gluconate as a single agent or in combination with alcohol. These products are
marketed as solutions, swabs, pads saturated with a solution, and applicators containing a solution. Currently available as both single-use and
multiple-use products.
Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling
stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms. However, even topical
antiseptics manufactured with a sterile process, can become contaminated if proper care is not taken when using them. The term nonsterile on the
product label means it was not sterilized during manufacturing; it does not mean the product contains harmful bacteria.
To further reduce the risk of infection with improper topical antiseptic use and the possibility of these products becoming contaminated with bacteria
during use, we are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use
containers.
To reduce the risk of infection, ensure the products are used according to the directions on the label.
39/166
4/6/2016
FDASafetyAlerts
The antiseptics in these single-use containers should be applied only one time to one patient.
We also recommend that health care professionals and patients do not dilute antiseptic products after opening them.
Applicators and any unused solution should be discarded after the single application.
Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis
(posted 11/6/2013)
The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing of spinal catheter
placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time
interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural
procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to
the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.
Epidural or spinal hematomas are a known risk of enoxaparin in the setting of spinal procedures and are already described in the Boxed Warning and
the Warnings and Precautions sections of the labels for Lovenox and generic enoxaparin products. However, these serious adverse events continue to
occur (see Data Summary). To address this safety concern, FDA worked with the manufacturer of Lovenox, Sanofi-Aventis, to further evaluate this risk
and to update the Warnings and Precautions section of the Lovenox label with these additional timing recommendations. The labels for generic
enoxaparin products will also be revised accordingly, as will those of other low molecular weight heparin-type products.
It is important to note that all anticoagulants carry the risk of causing spinal bleeding when used in conjunction with epidural/spinal anesthesia or
spinal puncture. We are continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed.
Health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a
preprocedure checklist, whether a patient is receiving anticoagulants and identify the appropriate timing of enoxaparin dosing in relation to catheter
placement or removal. To reduce the potential risk of bleeding, consider both the dose and the elimination half-life of the anticoagulant:
For enoxaparin, placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as
those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic
doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily).
A postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.
In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and
40/166
4/6/2016
FDASafetyAlerts
patient risk factors.

Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe
(posted 11/2/2013)
The Perrigo Company announced that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant
suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under store brand products including Babies R Us, Care One
and more (refer to the Firm Press Release for full list of affected brand names and products).
The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose
markings. Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.
This over the counter product is indicated for the relief of fever and minor aches and pains and can be used in infants, children and adults. These
recalled products are sold by distributors nationwide and distributed through retail stores.
If the oral dosing device contained in the package has dose markings (for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL), no action is required, and the
consumer can continue to use the product consistent with the label instructions. If the package contains an oral dosing device that does not have dose
markings, the consumer should not use the product and should call Perrigos Consumer Affairs Department, toll free, 1-800-719-9260. Consumers
should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly
be related to this drug product.
Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins
(posted 10/11/2013)
FDA is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and
veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib). Data from clinical trials and postmarket adverse event reports show that
serious adverse events have occurred in patients treated with Iclusig, including heart attacks resulting in death, worsening coronary artery disease,
stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to
restore blood flow. FDA is actively working to further evaluate these adverse events and will notify the public when more information is available.
Iclusig is a prescription medicine used to treat adults diagnosed with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML)
or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), who are no longer benefiting from previous treatment or who did not
tolerate other treatment. At the time of Iclusigs approval in December 2012, the drug label contained information about the risks of blood clots in the
Boxed Warning and Warnings and Precautions sections. In clinical trials conducted before approval, serious arterial blood clots occurred in 8 percent of
Iclusig-treated patients, and blood clots in the veins occurred in 3 percent of Iclusig-treated patients. In the most recent clinical trial data submitted
by the manufacturer to FDA, at least 20 percent of all participants treated with Iclusig have developed blood clots or narrowing of blood vessels.
Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.
41/166
4/6/2016
FDASafetyAlerts
Patients taking Iclusig should seek immediate medical attention if they experience symptoms suggesting a heart attack such as chest pain or pressure,
pain in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble
talking, severe headache, or dizziness. FDA is providing this information to patients and health care professionals while it continues its investigation.
Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure
(posted 9/23/2013)
FDA is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily. FDA continues to learn of deaths
from accidental exposure to fentanyl patches.
Patients and health care professionals are reminded that fentanyl patches are dangerous even after theyve been used because they still contain high
amounts of strong narcotic pain medicine. Accidental exposure to these patches can cause serious harm and death in children, pets, and others.
In an effort to minimize the risk of accidental exposure to fentanyl patches, FDA is requiring the manufacturer of Duragesic to print the name and
strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers. The current ink color varies by
strength and is not always easy to see. This change is intended to enable patients and caregivers to more easily find patches on patients bodies and
see patches that have fallen off, which children or pets could accidentally touch or ingest. The manufacturers of generic fentanyl patches are being
requested to make similar changes.
Duragesic (fentanyl) patch is a strong prescription pain medicine that contains a narcotic opioid. It is marketed under the brand-name Duragesic and
also as generic products.
Patients should be aware that patches that are not stuck to the skin tightly enough may accidentally fall off a patient and stick to someone in close
contact, such as a child. Used fentanyl patches require proper disposal after use fold the patch, sticky sides together, and flush it down the toilet
right away. See the FDA Drug Safety Communication for additional information, including recommendations for patients, caregivers, and health
professionals, and a data summary.
Leiter''''s Compounding Pharmacy: Recall - Concerns of Sterility Assurance
(posted 9/12/2013)
Leiter''''s Compounding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range
Laboratories, Leiter''''s Compounding Pharmacy''''s independent testing laboratory.
Bevacizumab Lot No. 08052013@1, expiry 11/03/13
Bevacizumab Lot No. 08052013@4, expiry 11/03/13
Lidocaine/phenylephrine Lot No. 07302013@6, expiry 10/28/13
42/166
4/6/2016
FDASafetyAlerts
FDA investigators observed that methods used by the independent laboratory to assess sterility may have resulted in pharmacies receiving inaccurate
laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable.
The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
These products were dispensed to health care providers between 8/05/13 to 9/02/13 nationwide throughout the United States.
Leiter''''s Compounding Pharmacy is notifying prescribing Physicians by first class mail, telephone, and/or email and is arranging for return of all
recalled products. Facilities that have product which is being recalled should stop using and return to Leiter''''s Compounding Pharmacy.
Park Compounding Sterile Medication: Recall Concerns of Sterility Assurance
(posted 9/10/2013)
Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp:
11/3/2013 for injection in 10ml amber vials, to the consumer level. In a recent inspection, FDA investigators observed that methods used by Front
Range Laboratories to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results
obtained from the laboratory are not reliable. If there is microbial contamination in products intended to be sterile, patients are at risk of serious
infections which may be life threatening.
The prescription preparations were sold during May and June of 2013, in the following states: California and Indiana. The products would have been
sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).
Customers that have product which is being recalled should stop using it and contact Park Compounding to arrange for return of unused product.
Customers with questions regarding this recall can contact Park Compounding Center at 949-551-7195 or at info@parkrx.com. Monday through
Friday, 9am to 5pm PST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to
taking or using these preparations.
Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor
(posted 9/9/2013)
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications, Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS) 1%.
The recall is a result of concerns of sterility assurance with the specialty pharmacys independent testing laboratory, Front Range Laboratories. To
date, Avella has not received any reports of adverse events related to the recall.
Avella was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities
(e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. FDA has raised concerns
43/166
4/6/2016
FDASafetyAlerts
that test results obtained from Front Range Labs may not be reliable. Therefore, Avella decided to conduct this voluntary recall out of an abundance of
caution. The recalled products were dispensed directly to healthcare providers nationwide and the medications can be identified based on product
label and corresponding medication name and lot number (see firm press release for lot numbers).
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug
product. Patients and healthcare providers with questions regarding this recall can contact Avella at (877) 738-0797 Monday through Friday between
6am and 6pm Pacific Standard Time or via e-mail at QA@avella.com.
University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance
(posted 9/8/2013)
University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone
Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level (refer to Recall Notice for a detailed product list with affected
lot numbers and expiry dates). In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to
assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the
laboratory are not reliable. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be
life threatening.
The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013.The preparations would have been sold,
directly to customers by pick up and by mail.
Customers that have product which is being recalled should stop using it and contact University Compounding Pharmacy to arrange for return of
unused product. Customers with questions regarding this recall can contact University Compounding Pharmacy at 1875 Third Ave, San Diego CA
92101 619-683-2005.
Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these
preparations.
Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility
(posted 9/5/2013)
Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table in press release) due to inability to confirm that the
quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with
standards.
The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections. Medaus has not received any
reports of adverse events related to the products affected by this recall to date.
44/166
4/6/2016
FDASafetyAlerts
Medaus is notifying its customers by telephone and email, and is arranging for return of affected products. Health care facilities and customers that
have products which are being recalled should stop using the product and call Medaus at 800-526-9183 for instructions on returning the product for
a full refund. To return medication or request assistance related to this recall, patients and physicians should contact Medaus Pharmacy at (800) 5269183 , Monday through Friday, between 9 a.m. and 5 p.m. CDT.
Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance
(posted 8/27/2013)
Park Pharmacy & Compounding Center is voluntarily recalling two lots of products Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp:
12/10/2013 and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection, to the consumer level. In a recent
inspection, FDA investigators observed that methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate
laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.
The prescription preparations were sold during June and July of 2013, in California, Florida, New Mexico and Indiana. The products would have been
sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).
Customers with questions regarding this recall can contact Park Pharmacy & Compounding Center at 949-551-7195 or at info@parkrx.com. Monday
through Friday, 9am to 5pm PST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be
related to taking or using these preparations. Park Pharmacy & Compounding Center is notifying its customers by phone and mail and is arranging for
return of all recalled product lots. Customers that have product which is being recalled should stop using it and contact Park Compounding to arrange
for return of unused product.
JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
(posted 8/27/2013)
JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent
inspection by FDA of Front Range Laboratories of Loveland, Colorado, one of the contract testing labs used by JCB. If there is microbial contamination
in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
The following JCB Laboratories compounded products are subject to the recall: Sodium thiosulfate, 25% (250 mg/mL), Sodium citrate, 4% solution for
injection, Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, and Acetylcysteine, 20% solution for inhalation (see firm press release
for lot numbers). The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8, 2013, through Aug. 20, 2013. JCB
has not received any reports of adverse events related to this recall to date. In the recent inspection of Front Range Labs, the FDA stated it observed
that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving
inaccurate laboratory test results.
45/166
4/6/2016
FDASafetyAlerts
Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this
drug product. JCB has begun notifying its customers by telephone, email, fax and mail. To return product or request assistance related to this recall,
users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8:00 a.m. and 5:00 p.m. CDT.
Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination
(posted 8/27/2013)
Wellness Pharmacy, Inc. issues nationwide voluntary recall of certain sterile products due to laboratory results indicating microbial contamination. If
there is microbial contamination in medications intended to be sterile,patients are at risk of serious infections which may be life threatening. To date
Wellness Pharmacy has not received any reports of adverse events related to this recall.
This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods
used by Front Range Labs to assess sterility and other qualities (e.g.,strength and stability) may have resulted in Wellness Pharmacy receiving
inaccurate sterility test results on following products: Dexpanthenol 250 mg/mL, Magnesium Sulfate 50%, Methylcobalamin 1 mg/mL, Sodium
Phenylbutyrate 200 mg/mL,R.L. Glutathione 100 mg/mL, and Ascorbic Acid (cassava) 500 mg/mL (see firm press release for lot numbers). Recalled
medications were distributed to individual patients and to physician offices nationwide. These liquid medications are ineither clear or amber sterile
vials ranging in size from 1ml to 50ml. The medications can be identified by the label on each vial, which will have the name of the drug, strength or
concentration, lot number, use by date, and vial size.
To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800227-2627, Monday through Friday, between 9 a.m. and 4 p.m. CDT. Patients should contact their physician or health care provider if they have
experienced any problems that may be related to taking these medications.
Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections
(posted 8/11/2013)
Specialty Compounding, LLC has announced a voluntary nationwide recall of all lots of unexpired sterile products. The recall applies to all unexpired
sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms. The recall was initiated after reports of bacterial
infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area,
whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and
the medication at this time.
Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located
nationwide with the exception of North Carolina.
Refer to the Firm Press Release for additional details.
46/166
4/6/2016
FDASafetyAlerts
Bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by Specialty Compounding, Cedar Park,
TX.
FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2
grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream
infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium
gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.
FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these
bacterial infections.
Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.
FDA is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX.
Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions
(posted 8/2/2013)
FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions.
Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products.
These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis
(AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat
fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing
serious skin reactions, which is already described in the warnings section of their drug labels.
This new information resulted from the Agencys review of the FDA Adverse Event Reporting System (FAERS) database and the medical literature to
evaluate cases of serious skin reactions associated with acetaminophen (see Data Summary at link below). It is difficult to determine how frequently
serious skin reactions occur with acetaminophen, due to the widespread use of the drug, differences in usage among individuals (e.g., occasional vs.
long-term use), and the long period of time that the drug has been on the market; however it is likely that these events (i.e., SJS, TEN, and AGEP) occur
rarely.
Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an
association, when assessing patients with potentially drug-induced skin reactions. Any patient who develops a skin rash or reaction while using
acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away. Anyone who has experienced a
serious skin reaction with acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain
relievers/fever reducers.
47/166
4/6/2016
FDASafetyAlerts
FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin
reactions. FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of OTC acetaminophen drug
products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the
same.
Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance
(posted 8/1/2013)
Beacon Hill Medical Pharmacy and FDA is notifying health professionals and consumers of the recall of all lots of certain sterile products. FDA has
raised a question of sterility assurance for the affected products.The products were distributed nationwide to outlets including hospitals, clinics, and
patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield,
Michigan.
Microbial contamination of products intended to be sterile can lead to serious infections, which may be life-threatening.
The list of sterile injectable products compounded by Beacon Hill/Rxtra Solutions and under recall, in alphabetical order, organized by drug name and
strength can be found in the firm''s press release at the link below. The products can be identified by lot numbers starting with code 01012013@1 to
07262013@99.
Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result
(posted 7/29/2013)
Nova Diabetes Care initiated a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental
USA. Nova Max Plus glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.
The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and
Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. A false abnormally high blood glucose result could, under
certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.
Upon identifying the issue, Nova Diabetes Care promptly notified all registered users, health care professionals, pharmacies, and distributors where
the Nova Max Glucose Test Strip and Nova Max Plus glucose meter kit are recommended or sold.
Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or
distributing glucose test strips from the recalled lots (see the Recall Notice for a listing of recalled lots).
Customers can check to confirm if they have blood glucose test strips from the affected lots on the attached list, by visiting
www.novacares.com/news/nova-max-recall.php or by contacting Nova Diabetes Care customer service at 1-800-681-7390.
48/166
4/6/2016
FDASafetyAlerts
People with Diabetes should be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Customers should
contact their healthcare professional for advice on how to treat the symptoms.
Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems
(posted 7/26/2013)
FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drugs use, warning that it can cause severe liver
injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. FDA has approved label
changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any
fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal
therapies are not available or tolerated.
Liver Injury (Hepatotoxicity)
Nizoral tablets can cause liver injury, which may potentially result in liver transplantation or death. FDA has revised the Boxed Warning, added a strong
recommendation against its use (contraindication) in patients with liver disease, and included new recommendations for assessing and monitoring
patients for liver toxicity.
Adrenal Insufficiency
Nizoral tablets may cause adrenal insufficiency by decreasing the bodys production of corticosteroids.
Drug Interactions
Nizoral tablets may interact with other drugs a patient is taking and can result in serious and potentially life-threatening outcomes, such as heart
rhythm problems.
See the FDA Drug Safety Communication for additional information, including a Data Summary.
Nizoral (ketoconazole) is indicated for the treatment of fungal infections when alternatives are not available or not tolerated. The topical formulations
of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams,
and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.
Nizoral tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks and
alternative therapeutic options are not available or tolerated. Healthcare professionals should assess the liver status of the patient before starting oral
ketoconazole, and monitor serum ALT levels during treatment. Adrenal function should be monitored in patients with adrenal insufficiency or with
49/166
4/6/2016
FDASafetyAlerts
borderline adrenal function and in patients under prolonged periods of stress (major surgery, intensive care, etc.). Review all concomitant medications
for the potential for drug interactions with Nizoral tablets.
Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for Over or Under Delivery of Insulin
(posted 7/12/2013)
On June 7, 2013, Medtronic sent an urgent medical device safety notification to healthcare professionals to inform them of the potential for over or
under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. On June 10, 2013 Medtronic sent an
Urgent Medical Device Safety Notification to all Paradigm Insulin pump users and distributors to inform them of this issue. If insulin or other fluids
come in contact with the inside of the tubing connector it can temporarily block the vents that allow the pump to properly prime. This can result in too
much or too little insulin being delivered, resulting in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.
Refer to the Recall Notice for a list of affected models. Affected products were manufactured from October, 2001 through June, 2013 and distributed
from December, 2001 through June, 2013.
Infusion sets are used by patients with diabetes mellitus who require administered insulin to maintain acceptable blood glucose levels. The Paradigm
infusion sets are intended for use with Paradigm insulin infusion pumps.
Patients: if you notice anything unusual during the infusion set prime process such as the insulin continuing to drip from the tip of the infusion set
cannula when priming has been completed, this may indicate that the connector vents are not working properly. If this occurs, do not insert the
infusion set and immediately call the HelpLine at 1-888-204-7616 for assistance.
Healthcare professionals: no action is required beyond the recommendations provided in the Urgent Medical Device Safety Notification letter.
Estarylla (norgestimate and ethinyl estradiol): Recall
(posted 7/5/2013)
Sandoz notified the public it is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl
estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack.
The lot number, expiration date, and NDC code of the recalled lot is: LF01213A, expiration date 02/2014, NDC 00781-4058-15. It is supplied in
cartons containing 3 blister cards of 28 tablets each. This lot was distributed to the US market only.
Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week.
Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets
50/166
4/6/2016
FDASafetyAlerts
(posted 6/12/2013)
Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level.
Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.
Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be
more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system)
could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.
The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of
thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent
myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Product is packaged in
HDPE Bottle of 1000''s count, which may have been dispensed to patients in smaller bottles. The only lot affected of Warfarin 2 mg Tablets being
recalled is Lot MM5767.
The product can be identified by its NDC #6838205310. The product was distributed nationwide in the United States to wholesalers/distributors,
retailers and mail order providers, from November 2012 to December 2012.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this
particular lot of Warfarin 2 mg Tablets.
Anyone with an existing inventory of this particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution, quarantine the recalled
lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. In
case patients have tablets of this lot of product, make sure all the tablets are of same size and if unsure, patients should consult their dispensing
pharmacy.
Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
(posted 5/30/2013)
Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by
the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality
control procedures that impacted sterility assurance. In the event a sterile product is compromised patients are at risk for serious and possible life
threatening infections.
The recall includes all sterile products that Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use by date of
09/25/2013 or earlier. Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy.
To date, Lowlite has received no reports of injury or illness associated with the use of the affected products.
51/166
4/6/2016
FDASafetyAlerts
Consumers or health care providers with questions regarding this recall may contact Lowlite by phone at 888-323-7788 or 407-673-2222 from the
hours of 9:00AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: Brian@olympiapharmacy.com. Patients
who have received any product furnished by Lowlite and have concerns should contact their healthcare provider.
Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor
(posted 5/30/2013)
FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant
women. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in
the developing baby or fetus, including thin bones (osteopenia), and fractures. The shortest duration of treatment that can result in harm to the baby
is not known. See the Data Summary in the Drug Safety Communication for additional information.
This use of the drug is off-label, and is not an FDA-approved use of the drug. Magnesium sulfate is approved to prevent seizures in preeclampsia, a
condition in which the pregnant woman develops high blood pressure and protein in the urine, and for control of seizures in eclampsia. Both
preeclampsia and eclampsia are life-threatening complications that can occur during pregnancy. Preeclampsia can lead to eclampsia, seizures, stroke,
multiple organ failure, and death of the woman and/or baby.
In light of this new safety information about low calcium levels and bone problems in the developing baby, the following information is being added to
the drug label for Magnesium Sulfate Injection, USP 50%:
A new Warning stating that continuous administration of magnesium sulfate injection beyond 5-7 days in pregnancy for the treatment of pre-term
labor can cause low calcium levels and bone changes in the baby.
A new Teratogenic Effects section conveying the potential harm to developing babies by changing the Pregnancy Category to D from A. Pregnancy
Category D means there is positive evidence of human fetal risk, but the potential benefits from using the drug in pregnant women may be acceptable
in certain situations despite its risks.
A new Labor and Delivery section emphasizing that continuous administration of magnesium sulfate injection to treat pre-term labor is not approved
and that the safety and efficacy of use for this indication are not established. When used in pregnant women for conditions other than its approved
indication, magnesium sulfate injection should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical
care facilities.
Pregnant women should discuss with their health care professional the possibility of going into labor before term and the risks and benefits of any
treatments that may be used.
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
52/166
4/6/2016
FDASafetyAlerts
(posted 5/28/2013)
Main Street Family Pharmacy, LLC has announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The
compounded products that are subject to the recall are those with a use by date on or before November 20, 2013. The recall is being initiated due to
seven (7) reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact
source of the adverse events is still ongoing.
These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were
distributed nationwide.
NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk

(posted 5/22/2013)
Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis
machines). Bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The dialysis filter (dialyzer) and the use of the Diasafe
filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely.
The affected lots are being recalled because they may develop higher bacteria levels than is allowed by the companys internal specification during
their shelf life.
Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity (salt
concentration).
A list of the 56 lot numbers of product which should be permanently removed from use and returned is available at www.fmcna.com disclaimer icon.
Customer notifications were published on April 10th and May 1st, 2014.
All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
(posted 5/18/2013)
FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision
Pharmacy of Dallas, Texas. The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators
observed poor sterile production practices that raise concerns about a lack of sterility assurance of the companys sterile drug products. The agency is
not aware of any additional adverse event reports associated with other sterile products from NuVision.
In April 2013, NuVision recalled Methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns
associated with the quality control processes identified during the FDA inspection. The FDA received adverse event reports of fever, flu-like symptoms,
and soreness at the injection site associated with the Methylcobalamin injection product that was previously recalled.
53/166
4/6/2016
FDASafetyAlerts
For all sterile products from NuVision, the FDA recommends that health care providers and other health care professionals, including hospital staff,
immediately check their medical supplies for NuVision sterile products, quarantine those products, and not administer them to patients. Patients who
were administered any sterile drug products produced and distributed by NuVision and who have concerns should contact their health care provider.
Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance
(posted 5/17/2013)
Pentec Health, Inc. initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated
with one of its laminar flow hoods used in compounding. Pentec Health has received no reports of injury or illness associated with any of the
prescriptions subject to this recall. However, because patients are at increased risk of infection in the event a sterile product is compromised, the
pharmacy is recalling any unused product whose beyond-use date has not passed.
These renal therapies were supplied to renal dialysis centers and directly to patients. Pentec Health is directly notifying each dialysis center and inhome dialysis patient of the recall. Prescriptions for a total of 163 patients are included in the scope of this recall. The recall covers renal therapies
that were compounded in this hood on or before May 2, 2013. Sterility tests associated with the compounding hood involved, as well as testing of
finished products made in the hood, have shown sterility.
Consumers or health care providers with questions regarding this recall may contact Pentec Health by phone at 800-223-4376, prompt 7, or e-mail at
recall@pentechealth.com, Monday through Friday, between 9:00 am and 8:00 pm EDT. Patients who have received any prescriptions prepared by
Pentec Health and have concerns should contact their health care provider.
The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
(posted 5/8/2013)
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDAs preliminary
findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at
and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial
contamination, it potentially places patients at risk of serious infection.
The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The
Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.
The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that
raise concerns about a lack of sterility assurance of The Compounding Shops sterile drug products.
Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding
54/166
4/6/2016
FDASafetyAlerts
Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received
any product produced by The Compounding Shop and have concerns should contact their health care provider.
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion
(posted 5/6/2013)
The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab
emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors.
The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products
could lead to dosing errors and potential harm to patients.
The FDA-approved nonproprietary name for Kadcyla, ado-trastuzumab emtansine, should be used. However, some third-party publications,
compendia references, health information systems (e.g., electronic health record systems and systems used for pharmacy prescription processing,
wholesaler ordering, pharmacy ordering, etc.), and sites on the Internet are incorrectly using the United States Adopted Name (USAN), which is
trastuzumab emtansine, and omitting the ado prefix and hyphen. Use of this truncated version of Kadcylas nonproprietary name may cause
confusion with Herceptin (trastuzumab).
It is important for drug information content publishers to identify drug products by the FDA-approved proprietary (brand) and nonproprietary names
that are used in FDA-approved drug labels. This will help prevent medication errors and ensure adverse events are reported for the correct product.
No medication errors related to confusion between Kadcyla and Herceptin have been reported to FDA since approval of Kadcyla on February 22, 2013;
however medication errors did occur during the clinical trials that evaluated its safety and efficacy prior to approval.
Kadcyla is used to treat HER2-positive breast cancer that has spread to other parts of the body in patients who have received prior treatment with
Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is made up of trastuzumab, an anti-HER2 therapy, connected to a drug called DM1 that
interferes with cancer cell growth.
Health care professionals should use both the FDA-approved proprietary (brand) name Kadcyla and its nonproprietary name (ado-trastuzumab
emtansine) when communicating medication orders, on preprinted order sets, and in computerized order entry systems. Such redundancy may help to
reduce the potential for medication errors. Additionally, strategies should be employed to warn against confusion between Kadcyla (ado-trastuzumab
emtansine) and Herceptin (trastuzumab) in medication-related computer systems.
Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or
Death
(posted 4/30/2013)
FDA has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying
55/166
4/6/2016
FDASafetyAlerts
liver disease because it can cause liver injury, potentially leading to liver transplant or death. FDA has worked with the manufacturer to revise the
Samsca drug label to include new limitations.
Samsca is a selective vasopression V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic
hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). An increased risk of liver injury was
observed in recent large clinical trials evaluating Samsca for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD).
Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use
should be avoided in patients with underlying liver disease, including cirrhosis. Patients should be aware that Samsca may cause liver problems,
including life-threatening liver failure, and should contact their health care professional to discuss any questions or concerns about Samsca.
Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
(posted 4/26/2013)
FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by
pigment changes in the retina. FDA does not currently know if these changes are reversible. FDA is working with the manufacturer to gather and
evaluate all available information to better understand these events. FDA will update the public when more information is available.
Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older.
The skin discoloration in the reported cases appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or
toes, but more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and
inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner
in some patients. In some cases, retinal abnormalities have been observed in the absence of skin discoloration.
All patients taking Potiga should have a baseline eye exam and periodic eye exams that should include visual acuity testing and dilated fundus
photography, and may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG). Patients
who are taking Potiga and develop any changes in your vision or any discoloration of your skin, including of your lips and nail beds should contact
their health care professional right away. Patients should not stop taking Potiga without talking to their health care professional. Stopping such
treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures.
All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance
(posted 4/23/2013)
Nora Apothecary & Alternative Therapies announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have
not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with quality control processes that
present a lack of sterility assurance and were observed during a recent FDA inspection
56/166
4/6/2016
FDASafetyAlerts
The recall includes sterile products that Nora Apothecary & Alternative Therapies supplied to patients and offices of licensed medical professionals.
Specifically, the recall includes approximately 95 dosage units of sterile compounded products that the pharmacy supplied to offices of twelve licensed
medical professionals located within Indiana. Some patients that received products from those medical professionals may be live in states other than
Indiana. The recall also includes approximately 400 prescriptions compounded for patients within Indiana and four other states: four prescriptions for
patients in Illinois; and one prescription each for patients in Ohio, Florida and Tennessee. See the firm press release for a list of products.
The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the
pharmacy on or before Friday, April 19, 2013. To date, Nora has received no reports of injury or illness associated with the use of our sterile products.
Consumers or health care providers with questions regarding this recall may contact Nora Apothecary & Alternative Therapies by phone at 800-7290276 or 317-251-9547 from the hours of 9:30AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address:
pharmacist@noraapothecary.com. Patients who have received any product furnished by Nora Apothecary & Alternative Therapies and have concerns
should contact their healthcare provider.
Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance
(posted 4/22/2013)
Balanced Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not
expired. The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance. Patients are
at increased risk for infections in the event a sterile product is compromised. See the Press Release for a listing of affected products.
These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were furnished
nationwide. The sterile products include all injectables with the Balanced Solutions Compounding Pharmacy name.
Consumers or Health Care providers with questions regarding this recall may contact Balanced Solutions Compounding Pharmacy, LLC by phone at
407-936-2998 or 877-306-0008 from the hours of 9:30AM- 6:00PM Eastern Standard Time Monday-Friday or e-mail address at
pharmacist@bshrx.com. Patients who have received any product furnished by Balanced Solutions Compounding Pharmacy and have concerns should
contact their healthcare provider.
Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns
(posted 4/16/2013)
NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level.
The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA
inspection.
These products were supplied to the offices of licensed medical professionals. NuVision Pharmacys sterile products covered under this recall were
57/166
4/6/2016
FDASafetyAlerts
distributed nationwide. To date, NuVision Pharmacy has received no reports of injury or illness associated with the use of our sterile products.
However, out of abundance of caution and in the interest of our patients, NuVision Pharmacy has decided to voluntarily proceed with this recall
process.
NuVision Pharmacy is notifying its customers by fax or email to return the products to the pharmacy. Consumers or Health Care providers with
questions regarding this recall may contact NuVision Pharmacy by phone at 800-914-7435 on Monday through Friday from the hours of 10 am to 6
pm CST, or by e-mail at pharmacist@nuvisionpharmacy.com. Patients who have received any product distributed by NuVision Pharmacy and have
concerns should contact their healthcare provider.
Sterile Products Compounded, Repackaged, and Distributed by ApothCure: Recall - Sterility Assurance Concerns
(posted 4/16/2013)
ApothCure, Inc. is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is
being initiated due to the lack of sterility assurance and concerns associated with the quality control processes
The sterile products include all injectables with the clear message, Independently tested for sterility, noted on the vials as well as the ApotheCure
name. ApothCures sterile products covered under this recall were distributed nationwide and supplied to the offices of licensed medical
professionals. To date, ApothCure, Inc. has received no reports of injury or illness associated with the use of our sterile products. However, out of
abundance of caution and in the interest of our patients, ApothCure, Inc. has decided to voluntarily proceed with this recall process.
Consumers or Health Care providers with questions regarding this recall may contact ApothCure, Inc. by phone at 800-969-6601 or 972-960-6601
from the hours of 9:30AM-6PM central time Monday-Friday or e-mail address at pharmacist@apothecure.com. Patients who have received any product
distributed by ApotheCure and have concerns should contact their healthcare provider.
Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns
(posted 4/11/2013)
Green Valley Drugs notified healthcare professionals and their organizations about the recall of all lots of all sterile products compounded,
repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of
the recalled products (name, lot # and Beyond Use date) is linked from the press release or can be accessed at greenvalleymed.com. Green Valley
Drugs sterile products covered under this recall were distributed nationwide.
The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques. Green Valley has received no
reports of injury or illness associated with the use of the products.
Until further notice, healthcare providers should stop using all lots of sterile products and return them to the company. Consumers or healthcare
providers with questions regarding this recall may contact Green Valley Drugs by phone at 702-564-2079 Monday through Friday between the hours
58/166
4/6/2016
FDASafetyAlerts
of 9 am to 5 pm PST, or by e-mail at pharmacy@greenvalleymed.com. Patients who have received any product distributed by Green Valley Drugs and
have concerns should contact their healthcare provider.
Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed
(posted 3/27/2013)
Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since
January 1, 2013 to the user level, including all strengths, all dose forms, and all products within expiry date. Recent inspections conducted by the FDA
and the Massachusetts Board of Registration in Pharmacy found visible particulates (filaments) observed in vials of several different sterile
compounded products. See the Press Release for a listing of all products affected by this recall.
The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to
damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.
The products are used for a wide range of therapeutic uses, including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin
injections, and ophthalmic preparations. All products are packaged in glass vials. All products were distributed to patients and/or physicians offices
through Friday, March 22, 2013.
Products were distributed directly to patients and/or physicians offices located in some or all of the following states: California, Connecticut, Florida,
Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island,
Tennessee, Texas, Vermont, Virginia, and Wisconsin.
Users or recipients should discontinue use and return the recalled products to Pallimed. All users who received any of the recalled products have been
or will be notified by telephone, fax, electronic mail and/or regular mail of the recall. To return product, request assistance, or report complaints
related to this recall, users should contact Pallimed at www.pallimed.com and by telephone at (781) 937-3344, Monday through Friday, between 10:00
a.m. and 5:00 p.m.
Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance
(posted 3/21/2013)
Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance.
The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.
This expanded recall follows the firms initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with
serious eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these
endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to
permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19,
59/166
4/6/2016
FDASafetyAlerts
2012 and March 19, 2013.

Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the
company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday
through Friday between the hours of 10 am to 5 pm EST, or e-mail at clinicalrx@bellsouth.net. Patients who have received any product distributed by
Clinical Specialties Compounding and have concerns should contact their healthcare provider.
Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection
(posted 3/20/2013)
Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical
Specialties has received reports of five intra-ocular infections from physicians office and this is how the problem was identified.
This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes (see Press
Release for a list of lot numbers). This product would be administered by a licensed physician in a surgery or physicians office setting and syringes
were distributed to doctors offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.
Doctors that have product which is being recalled should stop using the Avastin immediately. Consumers with questions regarding this recall may
contact Clinical Specialties by phone at 866-880-1915 or e-mail address at clinicalrx@bellsouth.net Monday through Friday between the hours of 10
am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking
or using this drug product.
Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms
(posted 3/12/2013)
FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a
potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing
QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal
heart rhythms, or arrhythmias. FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well
as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the
heart.
FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the
antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an
increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax)
compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were
similar to those associated with azithromycin treatment.
60/166
4/6/2016
FDASafetyAlerts
Azithromycin is marketed under the brand names Zithromax and Zmax. FDA-approved indications for azithromycin include: acute bacterial
exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis,
uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease.
Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment
options for patients who are already at risk for cardiovascular events. FDA notes that the potential risk of QT prolongation with azithromycin should be
placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the
fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an
antibacterial drug.
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions
(posted 2/23/2013)
Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a
voluntary recall of all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious
hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.
To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported
serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions
following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received
Omontys in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these
being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.
Omontys (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and is packaged in
10 mg and 20 mg Multi-dose vials:
10mg Multi-dose Vials - NDC 64764-610-10 Lots C18685, C18881, C19258
20mg Multi-dose vials - NDC 64764-620-20 Lots C18686, C18696
All lots of Omontys are affected by this recall and distributed nationwide, including Puerto Rico and Guam, to dialysis centers via specialty distributors.
Dialysis organizations are instructed to discontinue use. Customers will be provided instructions on how to return the product to the manufacturer for
a refund. For customers with questions, please call 1-855-466-6689, 9:00 a.m. to 5:00 p.m. Eastern Standard Time, Monday through Friday.
Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
(posted 1/25/2013)
61/166
4/6/2016
FDASafetyAlerts
Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebocontrolled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients
treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in
serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher
than the maximum 60 mg daily dose approved for the treatment of hyponatremia.
Most of the liver enzyme abnormalities were observed during the first 18 months of therapy. Following discontinuation of treatment, all 3 patients
improved. An external panel of liver experts assessed these 3 cases as being either probably or highly likely to be caused by tolvaptan. These findings
indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury. These data are not adequate to exclude the
possibility that patients receiving Samsca for its indicated use of clinically significant hypervolemic and euvolemic hyponatremia are at a potential
increased risk for irreversible and potentially fatal liver injury.
Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic
hyponatremia. Samsca is not approved for the treatment of ADPKD.
Healthcare providers should perform liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia,
right upper abdominal discomfort, dark urine or jaundice. If hepatic injury is suspected, Samsca should be promptly discontinued, appropriate
treatment should be instituted, and investigations should be performed to determine probable cause. Samsca should not be re-initiated in patients
unless the cause for the observed liver injury is definitively established to be unrelated to treatment with Samsca.
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions
(posted 1/25/2013)
FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an
increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal
of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data
from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical
Research Institute (DCRI).
Previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart
attack, so FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program
restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks.
Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the
Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, FDAs concern is substantially reduced
and the rosiglitazone REMS program requirements will be modified. FDA is also requiring revisions to the rosiglitazone prescribing information and the
patient Medication Guide to include this new information.
62/166
4/6/2016
FDASafetyAlerts
Refer to the Drug Safety Communication for more details.

Rosiglitazone is a treatment option that can improve blood sugar control in some patients with type 2 diabetes.
Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most
appropriate. Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to
prescribe, dispense, or receive rosiglitazone medicines. As part of the REMS, sponsors will ensure that health care professionals who are likely to
prescribe rosiglitazone medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of rosiglitazone
medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new
information.
Pradaxa (dabigatran etexilate mesylate) - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves
(posted 12/19/2012)
The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa
(dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart
valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users
were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant
warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.
Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use)
of Pradaxa in patients with mechanical heart valves.
Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with a specific condition called non-valvular atrial
fibrillation (AF), a common heart rhythm abnormality that causes the upper chambers of the heart, or atria, to beat rapidly and irregularly. Pradaxa is
not indicated for patients with atrial fibrillation caused by heart valve problems.
Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. The use
of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been
evaluated and cannot be recommended. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care
professional as soon as possible to determine the most appropriate anticoagulation treatment. Patients should not stop taking anticoagulant
medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood
clots and stroke.
Heparin: Drug Safety Communication - Important change to heparin container labels to clearly state the total drug strength
(posted 12/6/2012)
63/166
4/6/2016
FDASafetyAlerts
FDA is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products.
This label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the
entire container of the medication followed by how much of the medication is in 1 milliliter (mL). These modifications will eliminate the need for health
care professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of
miscalculations that may result in medication errors.
Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures
that may increase the chance that clots will form, or to stop the growth of clots that have already formed in the blood vessels and to prevent blood
clots from forming in catheters that are left in veins over a period of time.
Health care professionals, caregivers, and patients should be aware that that there will be a transition period before and after the official
implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available
in the marketplace. To minimize the potential for medication errors, users should consider separating the supplies of current and revised labeled
heparin, and use all of the supplies of the current heparin before using products with the revised container label.
OTC Eye Drops and Nasal Sprays: Serious Adverse Events From Accidental Ingestion by Children
(posted 10/25/2012)
FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and
nasal decongestant sprays can result in serious and life-threatening adverse events. The eye drops and nasal sprays that have been involved in the
cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. The cases of accidental ingestion
reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as
nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor,
hypothermia, drooling, and coma have occurred. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye
drops or nasal spray can lead to serious adverse events in young children.
Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can
accidentally ingest the drug if the bottles are within easy reach. These products are sold under various brand names, as generics, and as store brands
(see List of Products, included in the Drug Safety Communication, below).
Consumers should store these products out of reach of children at all times. If a child accidentally swallows these eye drops or nasal decongestant
spray, call the National Capital Poison Center (1-800-222-1222) and seek emergency medical care immediately.
Fungal Meningitis Outbreak: FDA provides NECC Customer List
(posted 10/22/2012)
64/166
4/6/2016
FDASafetyAlerts
FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England
Compounding Centers Framingham, MA facility. The first list includes customer names and addresses, organized by state. The second list contains
the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the
quantities of product shipped, and the shipping date. The lists were prepared based on information provided by NECC, and FDA cannot vouch for the
completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete.
Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to
their facilities since May 21, 2012.
FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in
conjunction with eye surgery, or a cardioplegic solution,
The medication was shipped by NECC on or after May 21, 2012, and
The medication was administered to patients on or after May 21, 2012.
Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products
produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination. Now that we have shipping
information available, we are updating FDAs recommendation to health care providers so that they can focus their attention on following up with the
patients who are believed to be at greatest risk of receiving a contaminated product.
New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak
(posted 10/5/2012)
FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate
collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species
of the fungus.
Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That
product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding
Center (NECC) in Framingham, Massachusetts. CDCs interim data show that all infected patients received injection with this product.
FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and
cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of
Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and
surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.
Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product
65/166
4/6/2016
FDASafetyAlerts
that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased
from NECC until FDA provides further instructions regarding the disposition of these products.
Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at
this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for
additional information.
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination
(posted 10/5/2012)
FDA and Hospira announced it is initiating a voluntary user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL,
Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a leak was identified in the primary container
between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold, was noted in the solution.
When a primary container within an overwrap has a leak, there is an open pathway for contamination of the fluid. The overwrap is not sterile, and any
fluid which may have leaked out may become trapped within the overwrap and has the potential to be reintroduced into the primary container. If
contaminated solution is used on a patient, critical patient harm may result. Injections of mold could potentially lead to septicemia (blood stream
infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. Signs and symptoms
could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting.
The impacted product is Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL; NDC #0409-7929-09 Batch# 12-160-JT* Expiration Date
1DEC2013. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with
retention samples for this lot. This recall is being conducted as a precautionary measure.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-7688,
between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is
available.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent
Tablets
(posted 9/21/2012)
Watson Laboratories, Inc. notified the public of a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500
mg (Lot Numbers 519406A and 521759A, both with the expiry date April 2014, distributed between 6/27/2012 and 7/18/2012 to wholesale
distributors and retail pharmacies nationwide).
A complaint was received for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and
521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or
66/166
4/6/2016
FDASafetyAlerts
Acetaminophen.
Unintentional ingestion of excessive amounts of acetaminophen may potentially result in an adverse event, including liver toxicity, especially in
patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a
day. Acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Unintentional ingestion of
excessive amounts of hydrocodone may result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression,
particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, such as sedating
medications or certain antidepressants.
Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
Pharmacists and wholesalers are asked to check their inventories for lots 519406A or 521759A segregate any material from the lots, and to contact
GENCO Pharmaceutical Services at 1-800-950-5479 for instructions on product return.
Qualitest Issues Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the
Potential for Oversized Tablets
(posted 9/10/2012)
September 10, 2012 - Qualitest, a subsidiary of Endo Health Solutions (Nasdaq: ENDP), today issued a voluntary, nationwide retail level recall for one
lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg.
The recall includes the following product lot:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date
12/13.
It is possible that some tablets from lot C1440512A exceed the weight specification and could be super-potent for the ingredients Hydrocodone
Bitartrate and Acetaminophen.
Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take
more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver
toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3
alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times
resulting in liver transplant or death. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of
side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also
taking interacting medications, for example other sedating medications or certain antidepressants.
67/166
4/6/2016
FDASafetyAlerts
No injuries have been reported to date.

Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. The affected lot,
C1440512A, was distributed between May 14 and Aug. 3, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be
found on the side of the manufacturers bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink,
capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.
Consumers who have lot C1440512A should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot number
should consult their pharmacy or health care professional.
Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, segregate any material from the lot, and to contact MedTurn at
1-800-967-5952 for instructions on product return. Pharmacies that received lot C1440512A will receive a copy of this press release with their recall
notification information. In order to make your patients aware of this recall, please post the enclosed press release prominently in the pharmacy area.
For more information please contact Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST. Reports of
adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and
5 p.m. CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program
either on line, by regular mail, or by fax.
Revatio (sildenafil): Drug Safety Communication - Recommendation Against Use in Children
(posted 8/30/2012)
FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1
through 17) for pulmonary arterial hypertension (PAH).This recommendation against use is based on a recent long-term clinical pediatric trial showing
that: (1) children taking a high dose of Revatio had a higher risk of death than children taking a low dose and (2) the low doses of Revatio are not
effective in improving exercise ability. Treatment of PAH in children with this drug is an off-label use (not approved by FDA) and a new warning,
stating the use of Revatio is not recommended in pediatric patients has been added to the Revatio labeling.
Revatio is a phosphodiesterase-5 inhibitor used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood
pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients (WHO Group I).
Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a health care professional. Healthcare
professionals were reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not
recommended. See the Drug Safety Communication for the Data Summary from the randomized, double-blind, placebo-controlled clinical trial of 234
patients with PAH, 1 to 17 years of age with mild to moderate symptoms at baseline.
68/166
4/6/2016
FDASafetyAlerts
Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume
(posted 8/16/2012)
Hospira and FDA notified healthcare professional of a nationwide voluntraty recall of one lot of Hydromorphone Injection, USP, 2 mg/mL, (C-II), 1 mL
fill in 2.5 mL Carpuject, NDC 0409-1312-30, due to a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume.
Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory
depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.
The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 12720LL. The expiration date
is December 1, 2013 and was distributed in March May 2012. Hospira has not received any reports of adverse events related to this issue for this lot.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-873-0312 to
arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635
Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.
For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven
days a week.
Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect
(posted 8/16/2012)
Hospira and FDA notified healthcare professional of a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible
particles embedded in the glass to the user level. There may be potential for product to come into contact with the embedded particles and the
particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential
for patient injury where medical intervention may be required. Risks associated with this defect could include tissue necrosis in one or more
organsthat could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.
See the Press Release for a listing of affected product lot numbers and expiration dates.
The product is packaged in vials and indicated for the induction or maintenance of anesthesia in surgical patients or to initiate sleep in intensive care
units. The affected lots were distributed nationwide to wholesalers and direct customers from September 2011 through February 2012.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's
MedWatch Safety Information and Adverse Event Reporting Program.
Francks Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall
(posted 5/24/2012)
69/166
4/6/2016
FDASafetyAlerts
FDA is notifying all physicians and medical care organizations who have ordered any compounded product sold as a sterile preparation by Franck's
Compounding Pharmacy of Ocala, Florida, of the recall of all sterile products sold by Franck's since November 2011 due to the possibility of lack of
sterility.
The recall is being carried out to the user physician. An active investigation of this matter by the CDC and FDA is ongoing at this time. In March 2012,
FDA received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck's Pharmacy, during
eye surgeries. Clinicians in several states reported the adverse events. In April 2012, FDA received reports of eye infections in patients who were given
injections of Francks drug products containing triamcinolone during eye surgery.
FDA advises that any product received from Franck's since November 2011 not be used and customer/physicians follow the instructions provided by
Francks. FDA also recommends that any adverse events suspected to be associated with use of the products be reported to FDA.
Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume
(posted 5/23/2012)
FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira, Inc. The pre-filled
cartridges containing the products listed in the Drug Alert may be overfilled by at least twice the expected amount, resulting in potential overdose.
Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is
recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products would result in an
immediate shortage.
Hospira, Inc. has informed the FDA of the occurrence of overfilled Carpuject pre-filled cartridges containing morphine and hydromorphone following
complaints received from healthcare providers.
Subsequent inspection of retained product by Hospira found additional overfilled Carpuject pre-filled cartridges. The manufacturing problem thought
to be responsible for this overfilling has resulted in the risk for overfilled Carpuject pre-filled cartridges for as many as 280 lots of 15 different
Carpuject pre-filled cartridge products.
FDA is advising healthcare providers to follow the instructions provided with the medication and visually inspect and confirm that the Carpuject prefilled cartridge contains the labeled fill volume before dispensing and again before administering to patients.
Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume
(posted 5/14/2012)
Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single
Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if
70/166
4/6/2016
FDASafetyAlerts
overdosed, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including
circulatory collapse.
The affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed in September October 2011. It was
initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of
Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New
Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.
The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to
arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635
Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.
Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases
(posted 5/4/2012)
[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products
labeled as sterile from Francks during the ongoing investigation.
[UPDATED 04/20/2012] FDA issues second warning to physicians regarding cvertain compounded drugs from Franck's. FDA received reports of eye
infections in patients who were given injections of drug products containing triamcinolone during eye surgery.FDA has received reports of fungal
endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck's Pharmacy, during eye surgeries. Clinicians in
several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse
events.
The BBG was supplied by Francks Compounding Lab, Ocala, Florida. Francks Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G
and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S.
Immediately quarantine and return any remaining Brilliant Blue G product from Francks Compounding Lab. This includes all lots of Brilliant Blue G
received from Francks.
FDA requests that practitioners report to MedWatch any cases of endophthalmitis, fungal or bacterial, that occurred within the last six months,
associated with eye surgery in which Brilliant Blue G from any source was used.
FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (Patches)
(posted 4/18/2012)
71/166
4/6/2016
FDASafetyAlerts
FDA reminds patients, caregivers, and healthcare professionals of the importance of appropriate storage, use, application, and disposal of fentanyl
patches (including Duragesic and generic products) to prevent potential life-threatening harm from accidental exposure to the active ingredient,
fentanyl.
Recently, FDA evaluated a series of 26 cases of pediatric accidental exposures to fentanyl patches reported over the past 15 years. Of these 26 cases,
ten resulted in death and 12 in hospitalization. Sixteen of the 26 cases occurred in children two years old or younger.
Young children are at particular risk of accidental exposure to fentanyl patches. Their mobility and curiosity provide opportunities for them to find lost
patches, take improperly discarded patches from the trash, or find improperly stored patches, all of which may result in patches being placed in their
mouths or sticking to their skin.
Additionally, young children are at risk of exposure when being held by someone wearing a partially detached patch which can then transfer to the
child. Exposure of young children to a fentanyl patch can lead to serious adverse events even death, due to the amount of fentanyl present in the
patches. This can even occur with used patches which still contain a considerable amount of fentanyl.
The FDA previously alerted the public to the appropriate use and disposal of fentanyl patches in 2005 and 2006, following the receipt of reports of
death and life-threatening adverse events related to fentanyl overdose. The adverse events occurred when the fentanyl patch was used to treat pain in
patients who were not tolerant to opioids and when opioid-tolerant patients applied more patches than prescribed, changed the patch too frequently
or exposed the patch to a heat source. In these advisories, FDA reminded patients, caregivers, and physicians about the appropriate use and disposal
of patches.
Additionally, as part of a broader public awareness campaign about the proper disposal of medications in 2011, FDA advised consumers on the proper
disposal of fentanyl patches when they are no longer needed. FDA recommends that the adhesive side of the patch should be folded together and then
the patch should be flushed down the toilet.
Healthcare professionals are urged to educate their patients and caregivers about the appropriate use and disposal of fentanyl patches. Patients are
encouraged to review the fentanyl patch product label for the instructions for use.
Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen
(posted 2/27/2012)
Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035
mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg), because of a packaging error where select blisters were rotated 180 degrees within the card, reversing
the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. As a result of this packaging error, the daily
regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Norgestimate and Ethinyl Estradiol Tablets are used as an oral contraceptive, indicated for the prevention of pregnancy in women. The product was
72/166
4/6/2016
FDASafetyAlerts
distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011.
Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected
product should notify their physician and return the product to the pharmacy. See the Press Release for a listing of affected lot numbers, expiration
dates, and product photos.
Infants TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints
(posted 2/17/2012)
McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants TYLENOL Oral Suspension, 1 oz.
Grape. There were complaints from consumers who reported difficulty using the Infants TYLENOL SimpleMeasure dosing system. SimpleMeasure
includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or flow restrictor, at the top of the bottle to measure the proper
dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.
Infants TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the
United States.
If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes
of affected product. Consumers can visit www.tylenol.com1 for additional information.
Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets
(posted 2/1/2012)
Pfizer Inc. notified healthcare professionals and consumers that it recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots
of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may
contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. As a result of this packaging error, the daily
regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
These products are oral contraceptives indicated for the prevention of pregnancy. These products are packaged in blister packs containing 21 tablets
of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an
unplanned pregnancy.
Patients who have the affected product should notify their physician and return the product to the pharmacy. See the Press Release for a list of affected
lot numbers.
73/166
4/6/2016
FDASafetyAlerts
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk
(posted 1/9/2012)
Including the following products:
Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
Opana (oxymorphone hydrochloride) CII
Oxymorphone hydrochloride Tablets CII
PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
MORPHINE SULFATE Extended-Release Tablets CII
ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo
Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were
packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray
pill of one medicine ending up in the bottle of another product.
Opiates are potent medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only
three product mix-ups with respect to these products since 2009; all three were detected by pharmacists. Endo is not aware of any patient having
experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.
FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the
same.
Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps
including Excedrin, NoDoz, Bufferin, Gas-X Prevention
(posted 1/9/2012)
Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter products Excedrin, Bufferin, Gas-X Prevention and NoDoz. Reports
were received of chipped and broken pills and inconsistent bottle packaging clearance practices at the Lincoln, Nebraska facility, which could result in
the bottles containing foreign tablets, caplets, or capsules.
Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than
74/166
4/6/2016
FDASafetyAlerts
intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be
taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.
This voluntary recall pertains to all lots of select bottle packaging configurations from retailers of Excedrin and Nodoz products (expiry dates of
December 20, 2014 or earlier), and Bufferin and Gax-X Products (expiry dates of December 20, 2013 or earlier), in the United States.
All of the pills in the bottle should look the same. If patients find a pill that is different in shape, size, color, or markings, they should bring their
medicine bottle to their pharmacist and not take any of those pills.
Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors
(posted 12/22/2011)
The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for infants (160 mg/5 mL) is now available. This
change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the
80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.
Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu,
headache, minor sore throat, and toothache. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers, Triaminic, Infant/Pain
Reliever, Pedia Care, Triaminic Infants Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).
This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using
the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen. In addition to this change in concentration, this product may also be
packaged with an oral syringe instead of a dropper.
Read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use.
Use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Healthcare
professionals should provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
(posted 12/7/2011)
FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead
to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about
75/166
4/6/2016
FDASafetyAlerts
significant and sometimes fatal bleeds. In a

Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error
(posted 9/16/2011)
Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the
daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Select
blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.
These packaging defects do not pose any immediate health risks. Pharmacies are being instructed to contact consumers who have received affected
product.
Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care
provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment
(posted 9/1/2011)
FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure.
Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. The revised label states that
Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label
also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients.
The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the
manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.
Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic
medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in
patients with underlying renal impairment also increases with age.
These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancerrelated indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa as well as in the Reclast label. Dose
reductions for Zometa are provided for patients with renal impairment.
Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare
professionals should screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor
76/166
4/6/2016
FDASafetyAlerts
renal function in patients who are receiving Reclast.

Infection Risk from Repackaged Avastin Intravitreal Injections
(posted 8/30/2011)
The U.S. Food and Drug Administration (FDA) is alerting health care professionals that repackaged intravitreal injections of Avastin (bevacizumab) have
caused a cluster of serious eye infections in the Miami, Florida area.
The Florida Department of Health (DOH) notified FDA of a cluster of Streptococcus endophthalmitis infections in three clinics following intravitreal
injection of repackaged Avastin. Investigators traced the tainted injections to a single pharmacy located in Hollywood, Florida. The pharmacy
repackaged the Avastin from sterile injectable 100 mg/4 mL, single-use, preservative-free vials into individual 1 mL single-use syringes.
The pharmacy then distributed the Avastin to multiple eye clinics for use in treating patients. To date, FDA is aware of at least twelve patients in at
least three of these clinics who had eye infection. While all of these patients had visual deficits prior to their injections with Avastin, some of these
patients lost all remaining vision in that eye due to the endophthalmitis.
The agency and Florida health officials continue to investigate the cause of the infection. While the investigation is not yet complete, the common link
for the infections is the pharmacy that repackaged the Avastin and the single lot of Avastin used in the re-packaging.
Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility,
potentially putting the patient at risk for microbial infections. Health care professionals should ensure that drug products are obtained from
appropriate, reliable sources and properly administered.
Avastin solution for intravenous infusion is approved for the treatment of various types of cancers. Some physicians also prescribe Avastin off-label for
the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication. Lucentis (ranibizumab injection)
has been approved by the FDA for wet age-related macular degeneration.
Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency

(posted 8/4/2011)
American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level. This
product recall was initiated by American Regent, Inc. because some vials may not maintain potency throughout their shelf-life. Potential adverse
events after administration of solutions that are below potency limits may include reduced effectiveness. See the company Press Release for a listing of
affected lot numbers. The products were distributed to wholesalers and distributors nationwide.
Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel
77/166
4/6/2016
FDASafetyAlerts
interfering gas shadows, and in diabetes insipidus.

Hospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities should not use American Regent, Inc., Vasopressin Injection, USP
Multiple Dose Vials with the lot #s listed for patient care and should immediately quarantine any product for return to American Regent Inc.
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
(posted 7/11/2011)
Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication
errors. The changes to the product label include:
A change in the concentration of Tamiflu from 12 mg/mL to 6 mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken,
which helps to ensure an accurate measurement.
A change in the measurements of the oral dosing device from milligrams (mg = weight) to milliliters (mL = volume).
A change in the dosing table for Tamiflu to include a column for the volume (mL) based on the new 6 mg/mL concentration. Revised container labels
and carton packaging. Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from Tamiflu capsules in an
emergency situation only if the commercially manufactured Tamiflu for oral suspension is unavailable.
Tamiflu is in a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body.
Genentech, the manufacturer of Tamiflu for oral suspension, plans to begin distribution of the new 6 mg/mL product in July 2011. The company has
instituted a voluntary Take Back Program for wholesale buyers, distributors and pharmacies to remove the 12 mg/mL product from the marketplace.
The 12 mg/mL product will remain in the marketplace and in state or national stockpiles until current supplies expire.
It is important for healthcare professionals to be aware that a patient may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their
pharmacy during the next influenza season (2011-2012). Steps should be taken to avoid the potential for a medication error due to confusion
between the two concentrations. Prescribers should include the new concentration (6 mg/mL) and dose in milliliters on all prescriptions for Tamiflu for
oral suspension.
Nationwide Recall of Two Lots of Endocet

(posted 6/27/2011)
Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg
78/166
4/6/2016
FDASafetyAlerts
100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV. One bottle from each lot of Endocet (oxycodone/acetaminophen, USP)
Tablets, 10 mg/325 mg, Lot # 402415NV and # 402426NV, NDC 60951-712-70, 100 count bottles, was found to contain some Endocet 10 mg/650
mg Tablets, which are identifiable by their larger size, and different shape and markings.
Qualitest Pharmaceuticals Voluntary, Nationwide Retail Level Recall
(posted 6/27/2011)
Qualitest Pharmaceuticals today issued a voluntary nationwide retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP,
50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg. This recall was initiated because an individual
bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone
Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B.
Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events
(posted 6/16/2011)
FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that
use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.
FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix
or placebo. While cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in
patients treated with Chantix than in patients treated with placebo. The events included angina pectoris, nonfatal myocardial infarction, need for
coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular
disease. FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis
(meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available.
See the Data Summary section of the Drug Safety Communication for additional information.
Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of
particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the
drug in smokers with cardiovascular disease.
Patients are encouraged to read the Medication Guide they receive along with their Chantix prescription.
Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion

(posted 6/13/2011)
79/166
4/6/2016
FDASafetyAlerts
FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of
ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
The FDA determined that the factors contributing to the confusion between the two products include:
Similarities of both the brand (proprietary) and generic (established) names
Similarities of the container labels and carton packaging
Illegible handwriting on prescriptions
Overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.
Risperidone (Risperdal) is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability
associated with autistic disorder. Ropinirole (Requip) is a dopamine agonist used in the treatment of Parkinsons disease and Restless Legs Syndrome.
Healthcare Professionals are reminded to clearly print or spell out the medication name on prescriptions and make certain their patients know the
name of their prescribed medication and their reason for taking it.
Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations
(posted 6/8/2011)
FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication
simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy
compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of
treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatinrelated myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal.
FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for
using simvastatin with certain medicines.
The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional
Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose
Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12
months or more without evidence of muscle injury (myopathy).
80/166
4/6/2016
FDASafetyAlerts
Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.
Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency
(posted 5/3/2011)
Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company
testing of tablets from a returned bottle found a tablet to be higher in potency than expected. The lot number affected in the U.S. is 9H49374A with an
expiry date of September 30, 2012. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if
there is too much active ingredient, there is an increased risk of bleeding.
Coumadin is prescribed to treat or prevent blood clots.
Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets
originating from the affected lot and if so, should consult their physician for appropriate medical advice.
Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral
Syringes and Feeding Tubes
(posted 4/15/2011)
The FDA has received reports that Tevas lansoprazole delayed-release orally disintegrating tablet has clogged and blocked oral syringes and feeding
tubes, including both gastric and jejunostomy types, when the drug is administered as a suspension through these devices. The tablets may not fully
disintegrate when water is added to them and/or they may disintegrate but later form clumps. These clumps can adhere to the inside walls of oral
syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged
or removed and replaced.
Lansoprazole is a proton pump inhibitor (PPI) medication. It is approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux
disease (GERD), erosive esophagitis (EE), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid).
Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release ODT product from distribution at this time. However, some product
may remain in stock in pharmacies and other facilities, and some patients may still have the product in their possession. The product may also be sold
under the following labels: Sharp Corporation, Cardinal Health, and Quality Packaging Specialist, Inc.
FDA recommends that healthcare professionals evaluate their medication stock and not dispense the Teva lansoprazole delayed-release ODT product
to patients for whom the product will be administered through an oral syringe or feeding tube.
Patients and caregivers should be instructed not to administer the Teva lansoprazole delayed-release ODT product through oral syringes and/or
feeding tubes due to the potential for clogging and blockage of the oral syringe or tube.
Read the Healthcare Professional Letter for other specific recommendations and for National Drug Code (NDC) numbers for the affected Teva products.
81/166
4/6/2016
FDASafetyAlerts
Topamax (topiramate): Recall - Musty Odor

(posted 4/15/2011)
Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is recalling two lots of Topamax (topiramate) 100mg Tablets. The
recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). While not
considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. There
have been no reported serious adverse events caused by the presence of TBA in Topamax.
Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; as
adjunctive therapy for adults and pediatric patients ages 2 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in
patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome; and for adults for the prophylaxis of migraine headache.
Patients taking Topamax 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their
pharmacist, and contact their healthcare professional if they have questions.
Benzocaine Topical Products: Sprays, Gels and Liquids: Risk of Methemoglobinemia
(posted 4/7/2011)
FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse
effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and
throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores,
and irritation of the mouth and gums.
Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most
severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale,
gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has
been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated
with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first
application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related
to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers
should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and
the Data Summary which supports these recommendations.
82/166
4/6/2016
FDASafetyAlerts
FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will
take appropriate regulatory actions as warranted.
Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market
(posted 3/2/2011)
FDA announced that it intends to remove certain unapproved prescription cough, cold, and allergy drug products from the U.S. market. Unapproved
prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater
risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).
Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs
labels do not disclose that they lack FDA approval.
Cough, cold, and allergy drug products are used to relieve symptoms associated with the common cold or upper respiratory allergies. These symptoms
may include coughing, chest congestion, nasal congestion, itchy eyes, and sneezing. Some cough, cold, and allergy products may be purchased over
the counter (OTC), while others require a prescription. See link below for a list of the unapproved prescription cough, cold, and allergy drug products
FDA intends to remove from the market.
Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss
alternatives.
Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall. Affected Products Include Amantadine, Amlodipine, Androxy,
Baclofen, Bethanechol, Jantoven and Oxybutynin
(posted 2/18/2011)
Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven Warfarin Sodium,
USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The
company is initiating the recall as a precautionary measure after a bottle labeled as Jantoven Warfarin Sodium, USP, 3 mg Tablets was found by a
retail pharmacy to contain tablets at a higher, 10 mg strength.
At Upsher-Smith, patient safety is of foremost concern. The substitution of warfarin, or any other product, may lead to a change in the therapeutic
effect of the intended drug.
Consistent, continuous dosing of any product is necessary for optimal care for many ill patients. Patients should check with their health care provider
regarding the appropriateness of their current therapy prior to making any change.
The expanded recall includes the following products:
83/166
4/6/2016
FDASafetyAlerts
Product Batch Number Expiration Date Product Identification

Amantadine 100 mg (100-ct bottles) 284166 Aug-12 Peach; imprinted AMT, 832
Amantadine 100 mg (100-ct bottles) 280603 Jul-12 Peach; imprinted AMT, 832
Amantadine 100 mg (100-ct bottles) 283797 Jul-12 Peach; imprinted AMT, 832
Amlodipine 5 mg (90-ct bottles) 280564 May-12 White; scored; imprinted ALP, 5, 832
Amlodipine 5 mg (90-ct bottles) 282661 Aug-12 White; scored; imprinted ALP, 5, 832
Androxy 10 mg (100-ct bottles) 283336 Sep-12 Green; scored; imprinted 86, 832
Baclofen 10 mg (90-ct bottles) 284651 Sep-12 White; scored; imprinted BAC, 10, 832
Baclofen 10 mg (90-ct bottles) 282346 Aug-12 White; scored; imprinted BAC, 10, 832
Baclofen 10 mg (100-ct bottles) 281664 Aug-12 White; scored; imprinted BAC, 10, 832
Bethanechol 5 mg (100-ct bottles) 282255 Aug-12 White; scored; imprinted BCL, 5, 832
Bethanechol 10 mg (100-ct bottles) 280569 Jun-12 White; scored; imprinted BCL, 10, 832
Bethanechol 25 mg (100-ct bottles) 280567 Jun-12 Yellow; scored; imprinted BCL, 25, 832
Jantoven 1 mg (100-ct bottles) 280617 Mar-12 Pink; scored; imprinted WRF, 1, 832
Jantoven 1 mg (100-ct bottles) 282872 Jul-12 Pink; scored; imprinted WRF, 1, 832
Jantoven 2 mg (100-ct bottles) 280598 Jun-12 Lavender; scored; imprinted WRF, 2, 832
Jantoven 2.5 mg (100-ct bottles) 281667 Jul-12 Green; scored; imprinted WRF, 2 , 832
Jantoven 3 mg (100-ct bottles) 280612 Jun-12 Tan; scored; imprinted WRF, 3, 832
Jantoven 3 mg (100-ct bottles) 284081 Sep-12 Tan; scored; imprinted WRF, 3, 832
Jantoven 4 mg (100-ct bottles) 283334 Jul-12 Blue; scored; imprinted WRF, 4, 832
Jantoven 5 mg (100-ct bottles) 280581 Jun-12 Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles) 283340 Jul-12 Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles) 283459 Sep-12 Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles) 283455 Jun-12 Peach; scored; imprinted WRF, 5, 832
Jantoven 6 mg (100-ct bottles) 282277 Jun-12 Teal; scored; imprinted WRF, 6, 832
Jantoven 6 mg (100-ct bottles) 284079 Sep-12 Teal; scored; imprinted WRF, 6, 832
Jantoven 7.5 mg (100-ct bottles) 280614 Aug-12 Yellow; scored; imprinted WRF, 7 ,
832
Jantoven 10 mg (100-ct bottles) 283342 Aug-12 White; scored; imprinted WRF, 10, 832
Jantoven 10 mg (100-ct bottles) 282917 Feb-12 White; scored; imprinted WRF, 10, 832
84/166
4/6/2016
FDASafetyAlerts
Oxybutynin 5 mg (100-ct bottles) 283368 Jul-13 White; scored; imprinted 38, 832
Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage
(posted 2/17/2011)
Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an
anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. To
date, the company has identified no additional mislabeled bottles.
The recalled lot is numbered as #284081, with an expiration date of September 2012. The product lot was distributed to wholesalers, retail chains and
independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3
times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.
The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the
3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The
10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832.
Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product
details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).
Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling
(posted 2/7/2011)
An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly
labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are
manufactured by Qualitest Pharmaceuticals.
As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital.
Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death,
especially in opioid nave patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in
patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a
day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
The recall includes the following products:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and
T023M10A
85/166
4/6/2016
FDASafetyAlerts
Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A
Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).
Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. Lot numbers can
be found on the side of the bottle.
Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication
(posted 1/13/2011)
FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products,
predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for
patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning
highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat,
difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter
(OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen
(Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this
action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing
to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year
implementation period should permit adequate time for necessary reformulations.
Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to
drink alcohol while taking acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain
medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional
information for healthcare professionals, information for patients, a data summary and a list of all affected products.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose
(posted 1/10/2011)
Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine
sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in
milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDAs unapproved drugs
initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container
label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions
86/166
4/6/2016
FDASafetyAlerts
intended to reduce the risk of medication errors.

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant
patients.
See Roxane's "Dear Healthcare Professional Letter" for a complete description and photos of labeling and product packaging changes. Changes
include:
A warning stating ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT is displayed in a box to highlight that the morphine sulfate oral solution
100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause
fatal respiratory depression when administered to patients not previously exposed to opioids.
The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is
to help differentiate this product from the 20 mg/5 mL morphine sulfate product.
A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL)
from other morphine sulfate oral solutions marketed by Roxane with a white background.
The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product
from other concentrations of morphine sulfate oral solutions.
A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.
Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to
provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the
oral syringe in order to help prevent medication errors from occurring.
Healthcare providers should discuss the correct use of the oral syringe with their patients.
Metronidazole Tablets, 250mg: Recall - Underweight Tablets
(posted 1/6/2011)
Teva Pharmaceuticals and FDA notified healthcare professionals and the public of a recall of Metronidazole Tablets USP, 250mg, lot #312566,
expiration date 05/2012. This product lot is being recalled due to the presence of underweight tablets. Underweight tablets may not contain the full
amount of active ingredient within a single tablet, and a consumer may not receive the prescribed dose. This may cause the infection the drug was
intended to treat to worsen or recur, which could be life-threatening when treating severe infections.
Metronidazole is indicated for the treatment of symptomatic and asymptomatic trichomoniasis, and treatment of asymptomatic consorts, amebiasis
and a variety of anaerobic bacterial infections. The affected Metronidazole lot is packaged in 250 count bottles and was distributed nationwide to
wholesalers and retailers.
Consumers who have lot 312566 in their possession are instructed to cease using the product and return it to their pharmacy.
87/166
4/6/2016
FDASafetyAlerts
Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
(posted 1/3/2011)
The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This
product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore,
represents a potential significant health hazard. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct
concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons. Administration of this defective product could result
in a range of potential health effects that spans from temporary and medically reversible to life threatening and death.
There is significant concern that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of product used
resulting in an administered amount that is 5 times the recommended dose. In the hospital setting, the vials are often not accompanied by the rest of
the packaging, making it more likely that such a dosing error could occur. Significant overdosing of a patient could lead to signs and symptoms of
albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid
heart rates up to 200 beats/minute.
This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and
exercise induced asthma in children and adults. The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a
shelf carton. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60
are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol
formulations or products are included in this recall. This product was distributed nationwide and Puerto Rico.
Consumers should immediately return the affected product to the place it was obtained (i.e. doctors office, pharmacy, etc.). Wholesalers and retailers
should return the product to the address stated in the firm Press Release.
Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
(posted 12/22/2010)
FDA and Abbott Diabetes Care notified healthcare professionals and patients of a recall of 359 different lots of glucose test strips marketed under the
following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The problem relates to a defect
that inhibits sufficient absorption of blood into the test strip. Strips exposed to warm weather or prolonged storage may be more likely to provide a
false result. Test strips with lot numbers that have been recalled may give falsely low blood glucose results, which can lead patients to try to raise their
blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. Both scenarios pose risks to health.
These strips are used with Abbotts Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose
monitoring systems. As many as 359 million strips may be affected by the recall. The test strips, which were manufactured between January and May
2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities.
88/166
4/6/2016
FDASafetyAlerts
Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children
(posted 12/14/2010)
FDA is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Overdose
with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Benzonatate may
be attractive to children because of the drug's appearance (it is a round-shaped liquid-filled gelatin capsule).
Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. The safety and effectiveness of benzonatate in
children under 10 years of age have not been established. Benzonatate is sold under the brand-name Tessalon and is also sold in generic
preparations. Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. Signs and
symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). Deaths in children have been reported within hours of the accidental
ingestion.
Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. If a child
accidentally ingests benzonatate, seek medical attention immediately. Signs and symptoms of benzonatate overdose can occur rapidly after ingestion
(within 15-20 minutes) and may include restlessness, tremors, convulsions, coma, and cardiac arrest.
Reese Pharmaceutical: Recall Mislabeled Guaifenesin Tablets
(posted 12/13/2010)
Reese Pharmaceutical Company has voluntarily recalled lot# 091612 only in 60-count size bottles identified under four different brand names, listed
below, because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were
mislabeled as containing only 200mg Guaifenesin tablets. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed
to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.
Refenesen Expectorant (guaifenesin 200 mg tablets)
Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)
QC Medifin Expectorant (guaifenesin 200 mg)
Leader Cough Tabs Expectorant (guaifenesin 200 mg)
The mislabeled product does not warn consumers that Acetaminophen may cause liver damage. Ingesting high doses of Acetaminophen can
potentially cause severe liver damage. The likelihood of acute liver damage is higher among consumers with pre-existing liver disease and those who
drink three or more alcoholic drinks per day. Overdose may specially occur if consumers are also taking other cold/cough products that contain
Acetaminophen in addition to the mislabeled product. Contraindications for Phenylephrine are high-blood pressure, poor blood flow to the
extremities, and patients on antidepressants known as MAO Inhibitors. Furthermore, products that contain Phenylephrine should be used with caution
in patients with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who
are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product.
89/166
4/6/2016
FDASafetyAlerts
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity

(posted 11/19/2010)
FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild
to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even
when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA
requested that the generic manufacturers of propoxyphene-containing products remove their products as well.
FDAs recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene
have on the heart (see Data Summary in Drug Safety Communication). The results of the new study showed that when propoxyphene was taken at
therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT
interval. These changes can increase the risk for serious abnormal heart rhythms.
FDA recommends that healthcare professionals stop prescribing and dispensing propoxyphene-containing products to patients, contact patients
currently taking propoxyphene-containing products and ask them to discontinue the drug, inform patients of the risks associated with propoxyphene,
and discuss alternative pain management strategies. Patients were advised to dispose of unused propoxyphene in household trash by following the
recommendations outlined in the Federal Drug Disposal Guidelines.
Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems
(posted 11/17/2010)
FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when
certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or
become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled
needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Adenosine is a
cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine
must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment.
In some cases where an attempt is made to connect to pin activated needleless IV access systems, the syringe may cause the pin to break thus
clogging the syringe, or damaging the IV tubing and/or the needleless connector and requiring reestablishment of a new intravenous access. These
failures can cause a delay in administration of the medication, which could potentially result in serious harm to patients.
Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. FDA has also received reports of problems related to certain
pre-filled needleless glass syringes containing the cardiac drug amiodarone. See the FDA letter for a list of affected adenosine and amiodarone
products.
Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications,
90/166
4/6/2016
FDASafetyAlerts
emergency drug boxes, or types of emergency drug caches should be alerted to this incompatibility problem and potential for damage or blockage of
the IV line and delay in administering the medication. Healthcare organizations currently using glass prefilled syringes should consider stocking
adenosine supplied in vials or pre-filled plastic syringes as a back up measure.
FDA has expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless
intravenous access systems, where delay in administration could potentially result in a life threatening event. FDA is working with manufacturers to
correct the problem and identify additional mitigation strategies.
Healthcare professionals and healthcare organization managers are encouraged to report adverse events or problems experienced with the use of
needleless pre-filled glass syringes to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. FDA is interested in receiving
information on the type, manufacturer and NDC numbers of the prefilled syringes and type and manufacturer of needleless IV access devices. FDA is
especially interested in any description of the nature of the syringe failure, any adverse patient outcomes, and any mitigation strategies that have been
identified or implemented by users of these products.
Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates
(posted 10/29/2010)
Sandoz and FDA notified healthcare professionals of a recall of Methotrexate Injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes
detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage
presentations.
Parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Potential adverse events
after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular
administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic
damage could result from intrathecal administration.
Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular
juvenile rheumatoid arthritis.
Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they
experience any problem that might be related to the use of this product. Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration.
Heparin Sodium (B. Braun): Recall - Trace Contaminant

(posted 10/29/2010)
91/166
4/6/2016
FDASafetyAlerts
B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical
Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were
manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.
Heparin is a blood thinner used to treat and prevent blood clots.
Customers who have product from the recalled product lots in their possession should discontinue use immediately. Product lot numbers, expiration
dates, and recall instructions are listed in the Press Release.
Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified
(posted 10/22/2010)
FDA notified healthcare professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved
specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression,
hypoventilation (slow breathing), and apnea (temporary suspension of breathing).
Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-theclock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate release opioids. The product is manufactured for Actavis by Corium International in the United States.
Wholesalers and retailers are being asked to return the product they have on hand or in stock. See the Press Release for recalled product lots. The
Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left
corner.
Tylenol 8 Hour Caplets 50 Count: Recall

(posted 10/19/2010)
McNeil is recalling TYLENOL 8 Hour caplets 50 count bottles to the retail level following a small number of complaints of a musty or moldy odor. The
uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.
This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil
were temporary and non-serious. The product lot number for the recalled product can be found on the side of the bottle label.
Consumers should stop using the affected product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036
(Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or
product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.
92/166
4/6/2016
FDASafetyAlerts
Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

(posted 9/23/2010)
FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with
Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk
of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose
(blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications,
metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS,
Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos
(pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the
medication if they choose to do so.
Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety
concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia
significantly.
Lamictal (lamotrigine) Label Change - Risk of Aseptic Meningitis
(posted 8/12/2010)
FDA notified healthcare professionals and patients that Lamictal (lamotrigine), a medication commonly used for seizures in children two years and
older, and bipolar disorder in adults, can cause aseptic meningitis. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting,
rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly
initiated.
The decision to revise the Lamictal label is based on FDA's identification of 40 cases of aseptic meningitis in patients taking Lamictal (from December
1994 to November 2009). See the Data Summary section of the Drug Safety Communication for additional information.
Patients should be advised to contact their healthcare professional immediately if they experience signs and symptoms of meningitis while taking
Lamictal. If meningitis is suspected, patients should be evaluated for other causes of meningitis and treated as indicated. Discontinuation of Lamictal
should be considered if no other clear cause of meningitis is identified.
Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms
(posted 8/2/2010)
93/166
4/6/2016
FDASafetyAlerts
FDA reminded healthcare professionals that oral nimodipine capsules should be given only by mouth or through a feeding or nasogastric tube and
should never be given by intravenous administration. Nimodipine is a medication intended to be given in a critical care setting to treat neurologic
complications from subarachnoid hemorrhage (ruptured blood vessels in the brain) and is only available as a capsule. Intravenous injection of
nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications.
In 2006, FDA added a Boxed Warning and made other revisions to the prescribing information to warn against intravenous use of nimodipine. The
prescribing information also provides clear instructions on how to remove the liquid contents from the capsules for nasogastric tube administration in
patients who are unable to swallow. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with "Not for IV
Use." FDA continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences.
The Drug Safety Communication provides additional information for Healthcare Professionals, for Patients, and a Data Summary of reported medication
errors. FDA will continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent
medication errors with this product.
Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
(posted 7/29/2010)
FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce
hot flashes during menopause. Children unintentionally exposed to the drug through skin contact with women may experience premature puberty.
Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.
Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. FDA is currently reviewing reported
adverse events and is working with the company to identify any factors that may contribute to unintended exposure. The Agency will update the public
when this review is complete. FDA and the company are also evaluating ways to minimize the risk.
Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was
applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site. Additional information
for Healthcare Professionals, Information for Patients, and a Data Summary are provided in the Drug Safety Communication.
Coumadin 1 mg Tablet Blister Packs: Recall
(posted 7/14/2010)
Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the
active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient
may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of
bleeding.
94/166
4/6/2016
FDASafetyAlerts
The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012;
HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or
any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure
that their anticoagulation therapy is not interrupted.
See the company Press Release for additional contact information.
Vitamin D Supplement Products: Medication Use Error
(posted 6/15/2010)
Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their
infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst,
frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious
consequences like kidney damage.
The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and
partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).
The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no
more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions,
FDA recommends consulting with a healthcare provider before giving any of these products to an infant.
Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors
(posted 5/12/2010)
Johnson & Johnson and FDA notified consumers and healthcare professionals of changes to the graphics and information displayed on the front of the
product container to reduce the risk of serious side effects from swallowing the topical Benadryl Extra Strength Itch Stopping Gel intended For Skin
Use Only". FDA received reports of consumers ingesting the gel rather than using it topically. Swallowing the gel can result in people receiving
dangerously large amounts of the active ingredient diphenhydramine.
Between 2001 and 2009, 121 cases of ingestion of Benadryl Extra Strength Itch Relief Gel were reported to the manufacturer. Of these cases, 7 were
considered serious because patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. Others
reported adverse events included hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and inability to speak.
McNeil Consumer Healthcare Over-the-Counter Infants and Childrens Products: Recall
(posted 4/30/2010)
95/166
4/6/2016
FDASafetyAlerts
McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Childrens and Infants
liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. Some of these products may not meet
required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents
and caregivers should not administer these products to their children. These products were distributed in the United States, Canada, Dominican
Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. Read the McNeil Press Release below for a
list of affected products. Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com
Name Change for Heartburn Drug Kapidex in effort to prevent medication errors
(posted 3/4/2010)
FDA Approves Name Change for Heartburn Drug Kapidex - change to Dexilant is part of FDA effort to prevent medication errors
The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two
other medications Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new
name Dexilant.
Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex
(bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.
Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex,
marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used
to treat pain.
The FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient
safety, said Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research.
The FDA evaluates new drug names before a product is approved to minimize confusion with existing drugs. Sometimes unexpected name confusions
can occur once the product goes to market.
To improve this safety process, the FDA has issued a new guidance for industry titled Contents of a Complete Submission for the Evaluation of
Proprietary Names. The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic
name, and to ensure compliance with other requirements for labeling and promotion.
These efforts are part of the agencys Safe Use Initiative which was launched in November 2009. The goal of this initiative is to reduce preventable
medical errors through collaboration with public and private institutions.
There will be no changes made to Kapidex other than its name. Health care professionals and other individuals responsible for ordering, stocking, and
96/166
4/6/2016
FDASafetyAlerts
billing for the product should be aware that Dexilant will have a new National Drug Code (NDC) number associated with the product.
Individuals and health care professionals who have questions about the name change should contact Takeda at 877-TAKEDA-7.
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
(posted 2/17/2010)
FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief
when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications
available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset
stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced
Maximum Strength are antacids.
Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is
chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or
have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral
infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs
such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.
The Drug Safety Communication and Consumer Update contain additional information for healthcare professionals and consumers, as well as product
label photos.
McNeil Consumer Healthcare Over-The-Counter Products: Recall
(posted 1/15/2010)
McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall. McNeil Consumer Healthcare has now applied broader
criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of
consumer complaints. Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil
Consumer Healthcare for instructions on a refund or replacement. The affected product names and lot numbers for the recalled products can be found
in firm's Press Release. Any adverse reactions may also be reported to the FDAs MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch,
FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging
(posted 12/9/2009)
Bayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold
Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot were printed with the label reversed. The label for the green
Night product appears under some of the blue Day product and vice versa. Consumers using the affected product lot may not be aware of the
97/166
4/6/2016
FDASafetyAlerts
warnings of an antihistamine in the product that could cause drowsiness.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as
well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo). This product was sold only in the
U.S. at retail outlets nationwide.
* Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
* UPC#: 016500537779
* Lot #: 296939L
* Expiration: 5/11
Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall
should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. See the company Press Release for
contact information
Local Anesthetics, Continuously Infused
(posted 11/13/2009)
FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular
infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were
infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss
of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional
surgery, including arthroscopy or arthroplasty (joint replacement).
Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local
anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps.
The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are
encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of
local anesthetics after orthopedic surgery.
This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and
references.
Dexferrum (iron dextran injection) - labeling change
(posted 10/16/2009)
American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral
98/166
4/6/2016
FDASafetyAlerts
administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic
dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test
dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies
may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and
treatment of anaphylactic-type reactions be readily available during Dexferrum administration.
Relenza (zanamivir) Inhalation Powder
(posted 10/9/2009)
GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir)
Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be
reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of
nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder
using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use
by nebulization have not been established.
Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug
product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or
intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical
ventilator equipment.
Heparin: Change in Reference Standard
(posted 10/1/2009)
FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and
test method used to determine the potency of the drug and able to detect impurities that may be present in heparin. The change, which will also
harmonize the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin
marketed in the United States.
This may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate
anticoagulant effect is clinically important. Healthcare providers should be aware of the decrease in heparin potency as they monitor the anticoagulant
effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
There will be simultaneous availability of heparin manufactured to meet the old and new USP monograph, with potential differences in potency.
Products using the new USP unit potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of
99/166
4/6/2016
FDASafetyAlerts
heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an N next
to the lot number. FDA is also working with the heparin manufacturers to study the impact of this variation in potency and will make the results
available when the studies have concluded.
Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors
(posted 9/24/2009)
FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension.
U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg).
The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing
instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is
in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
Promethazine Hydrochloride Injection
(posted 9/16/2009)
FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products,
describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The
Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular
injection and that subcutaneous injection is contraindicated.
Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and
tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of
injection, phlebitis, swelling, and blistering.
GDH-PQQ Glucose Monitoring Technology: possibility of falsely elevated blood glucose results
(posted 8/13/2009)
FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients
who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask
significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.
GDH-PQQ glucose monitoring measures a patients blood glucose value using methodology that cannot distinguish between glucose and other sugars.
Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the
metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that
healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving
interfering substances.
100/166
4/6/2016
FDASafetyAlerts
FDA encourages the voluntary reporting of any medical device adverse events related to glucose meters or glucose test strips that do not meet the
requirements for mandatory reporting. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone
[1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1800-FDA-0178].
Dextroamphetamine, Amphetamine 20 mg Tablets (Barr Laboratories) recall
(posted 8/13/2009)
Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and
Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20 mg Tablets, 100 count bottles, lot number 311756. The product is
being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.
Clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions.
Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor.
Colchicine (marketed as Colcrys)
(posted 7/30/2009)
FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial
Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral
colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug
interaction warnings.
FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored
pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard
therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug
interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine
toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine
was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events
compared to the higher dose.
Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and
is providing background information, a data summary and recommendations in this alert.
Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
(posted 7/16/2009)
Wyeth is voluntarily recalling a lot of Prevnar, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes. During a routine physical
101/166
4/6/2016
FDASafetyAlerts
reconciliation of Prevnar pre-filled syringes, Wyeth determined that a portion of a bulk lot of pre-filled syringes, which was not intended for
commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. The product distributed as Lot D50002 met
Wyeths quality acceptance criteria. Although some of the units of Lot D50002 were not intended for the commercial market, Wyeth performed a
medical assessment and has concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Prevnar pneumococcal 7-valent Conjugate Vaccine (Diptheria CRM197Protein)
0.5 mL single dose pre-filled syringe (10 per package)
NDC: 0005-1970-50 (10s)/0005-1970-49 (Singles)
Lot Number: D50002
Expiration Date: February 28, 2011
Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall
(posted 7/16/2009)
Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and
31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.
Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available
information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.
Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse
effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to
product with high endotoxin levels.
For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of
intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of
critically ill patients.
Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their
distributor.
102/166
4/6/2016
FDASafetyAlerts
Teva Pharmaceuticals USA is voluntarily recalling the aforementioned lots. FDA and CDC have been apprised of this action.
Consumers with questions may contact 1-866-262-1243 from 8:00 am 8:00 pm EDT Monday Friday.
Any adverse reactions experienced with the use of this product should also be reported to the FDAs MedWatch Program by phone at 1-800 FDA1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch.
Immunosuppressant Drugs: Required Labeling Changes
(posted 7/14/2009)
The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at
increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These
immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy
has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and early
intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK
virus-associated nephropathy.
FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare
professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting
program.
Brookstone Pharmaceuticals Issues a Voluntary Recall
(posted 7/14/2009)
Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated anationwide voluntary recall of all lots of Concentrated Acetaminophen Drops
(NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparableto the size generally used to package regular strength
acetaminophen liquid preparations.This aspect of the product coupled with the absence of an integrated dosage deliverydevice is a contributing factor
to possible dosing errors, especially inadvertentoverdosing. Brookstone has distributed 344 bottles nationally and has donated 5301bottles to charity
for international distribution.
Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blooddisorders. FDA is aware of several medication error reports that
document lifethreateningor fatal adverse events in children less than three years of age, due toconfusion associated with the concentrated versus
regular strength acetaminophen liquid.Also, in a recent FDA advisory panel, it was recommended that one of the two strengthsof acetaminophen
should be removed from the market due to possible confusion whichcould result in overdosing.
Brookstones concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL.Regular strength acetaminophen elixir contains 160 mg/5 ml. The
103/166
4/6/2016
FDASafetyAlerts
firm is recalling itsproduct to the consumer level as a cautionary measure to minimize any confusion andpotential risk to patients from dosing errors.
Brookstone Pharmaceuticals has notified customers that it has voluntarily stoppedmanufacturing and shipping Concentrated Acetaminophen Drops in
bulk containers andhas also advised customers (wholesalers and hospitals) to quarantine and hold the productfor return to Brookstone
Pharmaceuticals for a full refund. Customers with questionsabout the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802,option
2. Brookstone has not received any adverse events associated with this product butdue to recent advisory panel concerns, Brookstone has taken
voluntary action.
The recalled drops were manufactured by Pharmaceutical Associates, Inc. This recall isbeing conducted with the knowledge of the Food and Drug
Administration.
Customers who have this product in their possession should stop using it immediately.Any adverse events that may be related to the use of this
product should be reported tothe FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
MedWatch June 2009 Safety Labeling Changes
(posted 7/11/2009)
The MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes to the following sections:
BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised. Clicking on a drug product name in the Summary View will
take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified
safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections: Prometrium (progesterone), Reglan
(metoclopramide), Coreg (carvedilol), Prandin (repaglinide), Videx (didanosine), Amaryl (glimepiride), Aristospan (triamcinolone hexacetonide injectable
suspension, USP), Cancidas (caspofungin acetate), CellCept (mycophenolate mofetil), Combivent (ipratropium bromide and albuterol sulfate), Coreg CR
(carvedilol phosphate), Patanase (olopatadine hydrochloride), Rocephin (cefTRIAXone sodium), Strattera (atomoxetine hydrochloride)
Propoxyphene-containing Products
(posted 7/7/2009)
FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain
propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing
products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a
medication guide to patients stressing the importance of using the drugs as directed.
104/166
4/6/2016
FDASafetyAlerts
FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended
doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA
plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often
the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other
drugs.
Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
(posted 7/1/2009)
FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and
bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric
symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and
behavior, and attempted suicide. The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and
bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal
events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.
Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they
experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts
or behavior.
Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
(posted 6/17/2009)
FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following
publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA
reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has
determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its
approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are
conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyses likely will be
reported in approximately one year.
Zicam Cold Remedy Nasal Products
(posted 6/16/2009)
FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products (Cold Remedy Nasal Gel, Cold
Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) sold over-the-counter as cold remedies because they are associated with the loss of sense of
smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the
105/166
4/6/2016
FDASafetyAlerts
three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a
loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the
affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a persons quality of life, and can
limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.
Stimulant Medication in Children with AD/HD - Communication about an Ongoing Safety Review
(posted 6/15/2009)
FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential
risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the
National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died
suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that
there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this studys
methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in
children. FDA believes that this study should not serve as a basis for parents to stop a childs stimulant medication. Parents should discuss concerns
about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain,
shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.
FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications
used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide
further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete
later in 2009.
Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat
(dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER,
Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and
generics.
Levemir Insulin: Check personal supply of insulin to identify possible stolen and dangerous product.
(posted 6/13/2009)
FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold
in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who
use Levemir insulin to:
1) Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038.
2) Do not use your Levemir insulin if it is from one of these lots.
106/166
4/6/2016
FDASafetyAlerts
3) Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
4) Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.
Propylthiouracil associated with risk of serious liver injury and death
(posted 6/4/2009)
FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and
pediatric patients. Reports to FDAs Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with propylthiouracil
when compared to methimazole. FDA has identified 32 (AERS) cases (22 adult and 10 pediatric) of serious liver injury associated with propylthiouracil
use. Although both propylthiouracil and methimazole are indicated for the treatment of hyperthyroidism due to Graves disease, healthcare
professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves disease. Physicians should closely monitor
patients on propylthiouracil therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy.
Propylthiouracil should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment
options available.
Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
(posted 5/12/2009)
AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to
March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The
tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco
Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. The recalled product is a scored round biconvex white tablet imprinted with 441,
with an NDC number of 54569-5758-0 (30-count). Consumers with the product that are within expiration should return these products to their
pharmacy or place of purchase.
Tarceva (erlotinib): warning about GI perforation, exfoliative skin conditions and corneal perforation/ulceration
(posted 5/8/2009)
OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the
prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases
suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or
ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and
postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer
after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of
patients with locally advanced, unresectable, or metastatic pancreatic cancer.
Testosterone gel products: Boxed warning of risk of unintended secondary exposure of children
(posted 5/7/2009)
107/166
4/6/2016
FDASafetyAlerts
FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a
boxed warning on the products labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through
contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of
secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary
exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children
included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and
aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both
products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for
secondary exposure.
Hydroxycut Products
(posted 5/1/2009)
FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a
number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers,
as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.
FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver
damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures;
cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these
Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other
potentially serious side effects.
Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
(posted 4/30/2009)
FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin
products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the
effects of the toxin spread beyond the site where it was injected.
FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to
provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that
botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families,
and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of
children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.
108/166
4/6/2016
FDASafetyAlerts
Libimax - Recall of dietary supplement due to undeclared drug tadalafil

(posted 4/29/2009)
Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains
tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil may interact
with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes,
high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it
immediately and contact their physician if they experienced any problem that may be related to taking this product.
Dietary Supplements [Universal ABC Beauty Supply] - Recall
(posted 4/22/2009)
ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified
undeclared sibutramine, an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that these products pose a threat to
consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant
risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. See the firm's press release for a list of
affected products.
Influend Cough and Cold Products: Recall due to possibility of product being superpotent
(posted 4/16/2009)
ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008
due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and
cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. Customers who have this product in their
possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this
product.
Ceftriaxone: Update on interaction with calcium-containing products
(posted 4/14/2009)
FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products,
based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to
assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion
lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of ceftriaxone-calcium using
varying ceftriaxone and calcium concentrations, including concentrations in excess of those achieved in vivo. Based on the results from these studies,
FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients greater than 28 days of age, using the
precautionary recommendations noted because the risk of precipitation is low in this population. FDA had previously recommended, but no longer
recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another.
109/166
4/6/2016
FDASafetyAlerts
Raptiva (efalizumab) - Withdrawn from market

(posted 4/8/2009)
Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the
U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer
be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately
begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with
their health care professional to transition to alternative therapies for psoriasis.
Digoxin (Caraco brand) - Recall of tablets because they may differ in size
(posted 4/1/2009)
Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and
Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets
are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat
heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of
digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and
bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in
cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.
FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
(posted 3/31/2009)
The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in
several dosage forms and are widely used to treat pain. The FDA's warning letters notified the companies they may be subject to enforcement action if
they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and
immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.
Watson Announces Voluntary Recall of Propafenone HCL Tablets

(posted 3/25/2009)
FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to
treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified.
Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious
side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of
Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. The Press Release includes instructions for
identifying and returning the affected product.
110/166
4/6/2016
FDASafetyAlerts
Myfortic (mycophenolic acid) Medication Guide released

(posted 3/24/2009)
FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in
language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle.
Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.
DAYTRANA (methylphenidate transdermal system) patches
(posted 3/20/2009)
Shire plc announced today a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch DAYTRANA. Shire is taking this action
because some DAYTRANA patches no longer meet their release liner removal specification, and as a result, patients and caregivers could have
difficulties removing the liners. Physicians, patients, and caregivers who have questions about DAYTRANA should call Shires DAYTRANA customer
service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-202-3822.
Zencore Plus recalled due to product containing undeclared drug
(posted 3/20/2009)
Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company's supplement product sold under the
name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5
inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood
pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on
internet nationwide. Consumers who have this product in their possession should stop using it immediately.
Weight Loss Products - nationwide alert expanded
(posted 3/20/2009)
FDA expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The
FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients
(fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes 72 products.
Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use
(posted 3/19/2009)
The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin
pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen
to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result
in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control and
Prevention, professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of
111/166
4/6/2016
FDASafetyAlerts
insulin pens.
Transdermal Drug Patches with Metallic Backings
(posted 3/5/2009)
FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or
other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the
process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a
warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare
professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The
healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing
the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.
Metoclopramide-containing drugs: chronic use linked to tardive dyskinesia
(posted 2/26/2009)
FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed
warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia,
which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible
and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of
metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.
Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide
that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.
CellCept (mycophenolate mofetil) Medication Guide
(posted 2/12/2009)
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety
information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to
every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic
acid, marketed as Myfortic by Novartis.
Ethex recalls prescription prenatal vitamin and iron supplement products
(posted 2/4/2009)
ETHEX Corporation expanded the company's previous recall notices to include prescription prenatal vitamin and iron supplement products. See the
02/03/2009 Press Release (www.fda.gov/oc/po/firmrecalls/ethex02_09.html) for a list of products included in the recall.
Ethex Corporation Product Recall
112/166
4/6/2016
FDASafetyAlerts
(posted 1/27/2009)
FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products
recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic
products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these
products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional
products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their
possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place
patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or
using these products, or to obtain replacement medications or prescriptions.
Ther-Rx Corporation Nationwide Voluntary Recall of Products
(posted 1/26/2009)
Ther-Rx Corporation, a subsidiary of KV Pharmaceutical, is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a
voluntary nationwide recall of the products identified below (all lots within expiration) as a precautionary measure because they may have been
manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).
The Drug Safety Newsletter, Volume 2, Issue 1, 2009 is now available
(posted 1/16/2009)
The Drug Safety Newsletter (DSN), Volume 2, Issue 1, 2009 is now available. DSN is published online quarterly, and provides information for healthcare
professionals about the findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new
drugs. The newsletter is intended to complement other FDA methods of communicating drug safety information to the public. FDA also hopes the
newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.
Topical Anesthetics: reminder of potentially serious hazards of using skin numbing products
(posted 1/16/2009)
FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin
numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned
about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties,
coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional
organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical
anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.
HYDROmorphone HCl 2 mg Tablets (ETHEX Corp. and KV Pharmaceutical)
(posted 12/24/2008)
113/166
4/6/2016
FDASafetyAlerts
ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of HYDROmorphone HCl 2 mg Tablets due to potential for
oversized tablets. HYDROmorphone is a drug used for pain management. If someone were to take a higher than expected dose of HYDROmorphone,
the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing),
low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.
The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug
products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to
managements attention. See the full MedWatch 2008 Safety summary for links to the Ethex and KV press releases and a list of KV products affected by
the suspension.
Weight Loss Pills contain undeclared, active pharmaceutical ingredients
(posted 12/22/2008)
FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain
undeclared, active pharmaceutical ingredients that may put consumers' health at risk. The undeclared active pharmaceutical ingredients in some of
these products include sibutramine (a controlled substance), rimonabant ( a drug not approved for marketing in the United States), phenytoin ( an
anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). The weight loss
products, some of which are marked as "dietary supplements," are promoted and sold on various web sites and in some retail stores.
FDA advises consumers who use the products to stop taking them and consult their healthcare professional immediately as the health risks posed by
these products can be serious (for example, high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke). FDA also encourages
consumers to seek guidance from healthcare professional before purchasing weight loss products. See the FDA News Release for a listing of the names
of the 25 referenced products.
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available
without a prescription)
(posted 12/11/2008)
FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate
products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep,
and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing,
these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.
FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for
these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include
a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing
clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate
114/166
4/6/2016
FDASafetyAlerts
nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing
pursuant to a prescription from a healthcare professional.
Hospira's 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP
(posted 12/8/2008)
Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20
mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the
containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a
medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse
events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental
confusion. The affected lot was shipped to U.S. customers between July 2008 and September 2008. Healthcare facilities with an existing inventory
should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it.
Phenytoin and Fosphenytoin Sodium associated with potential increased risk of serious skin reactions
(posted 11/24/2008)
FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele
occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and
Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the
risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and
fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA,
and information for patients and healthcare professionals to consider, can be found in the links provided in the MedWatch safety alert.
Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)
(posted 11/12/2008)
Johnson & Johnson - Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of
Infants' Mylicon Gas Relief Dye Free Drops (Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008,
nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process.
Parents who have given the product to their infant and are concerned should contact their healthcare professional.
ETHEX Corporation - Nationwide Voluntary Recall of Five Generic Products
(posted 11/10/2008)
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate
Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate
Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the
115/166
4/6/2016
FDASafetyAlerts
active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or lifethreatening consequences.
Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate;
respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate.
Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall
notice for specific lot numbers of the products affected by this recall.
Dextroamphetamine Sulfate 5mg Tablets (Ethex)
(posted 10/16/2008)
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was
recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a
higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia,
hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their
caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with
any questions.
Over The Counter Cough and Cold Medications
(posted 10/9/2008)
FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product
labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA
members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA
continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines.
Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before
giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.
Tarceva (erlotinib)
(posted 9/23/2008)
OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported
during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely
monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or
discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment
values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with
significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS
and DOSAGE AND ADMINISTRATION sections.
116/166
4/6/2016
FDASafetyAlerts
Epoetin alfa - Early Communication about an Ongoing Safety Review

(posted 9/23/2008)
FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute
ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of
anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in
the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both
groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring
among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.
FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate
our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests
the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled
patients outweigh the risks in these trials.
Vivitrol (naltrexone)
(posted 8/12/2008)
FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the
treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is
administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue.
Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising,
pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening
injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone
injection.
Simvastatin Used With Amiodarone
(posted 8/8/2008)
FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used
with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a
revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater
than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers
should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin
greater than 20 mg per day in patients taking amiodarone.
Fluoroquinolone Antimicrobial Drugs
(posted 7/8/2008)
117/166
4/6/2016
FDASafetyAlerts
FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen
existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney,
heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain,
swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor
about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be
limited to those conditions that are proven or strongly suspected to be caused by bacteria.
Solodyn (minocycline HCL) Extended Release Tablets 90 mg
(posted 5/19/2008)
Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended
Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets.
Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking
Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the
elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects.
Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above.
Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the
manufacturer to return the product.
Use Caution with Over-the-Counter Creams, Ointments
(posted 4/1/2008)
Acne, cough due to a cold, athlete's foot, hemorrhoids, itching from insect bites, and minor aches and pains of muscles and jointsthese are among
the conditions that people treat by applying over-the-counter (OTC) creams and ointments to their skin. The Food and Drug Administration (FDA)
urges consumers to keep safety in mind when using such treatments.
FDA 101: Medication Errors
(posted 3/17/2008)
FDA has published a consumer-oriented article on efforts to reduce medication errors. The article discusses collaborative efforts undertaken by FDA,
USP, and ISMP.
Tussionex: Reports of life-threatening events and deaths
(posted 3/11/2008)
FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex
Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients
118/166
4/6/2016
FDASafetyAlerts
younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is
contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.
Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the
suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory
depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers
should use a properly marked measuring device to measure Tussionex to prevent overdose.
Spiriva & Foradil Capsules For Inhalation - Correct Use Of The Products
(posted 2/29/2008)
FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American
Association of Poison Control Centers (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil
capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil)
devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung
disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled.
Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory
for important information on the correct use of both products.
Cough and Cold Medications in Children Less Than Two Years of Age
(posted 1/17/2008)
FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-thecounter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age
group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information
the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October
18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety
of OTC cough and cold medicines in children 2 through 11 years of age.
Edetate Disodium (marketed as Endrate and generic products)
(posted 1/16/2008)
FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where
children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate)
or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an
emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems
as a result of very high amounts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe
lead poisoning).
119/166
4/6/2016
FDASafetyAlerts
The two drugs have very similar names and are commonly referred to only as EDTA. As a result, the two products are easily mistaken for each other
when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium works by binding with heavy metals or
minerals in the body allowing them to be passed out of the body through the urine.
Fentanyl Transdermal System - Updated Information On Appropriate Prescribing, Dose Selection, and Safe Use
(posted 12/21/2007)
FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal
system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and
safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl
overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied
more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use
in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer
than a week and are considered to be opioid-tolerant.
Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of
fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to
prevent death or other serious side effects from fentanyl overdose.
ISMP has written about this serious issue in past newsletters, which can be found at "Ongoing, preventable fatal events with fentanyl transdermal
patches are alarming!"
FDA Public Health Advisory for Fentora
(posted 9/26/2007)
FDA issued a Public Health Advisory and a Healthcare Professional Sheet to alert healthcare professionals and consumers regarding concerns over the
use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of improper
selection of patients, dosing, or improper product substitution.
FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in
patients who are not opioid tolerant.
Patients also must be under a doctors care and close supervision while taking Fentora and the dose should be carefully adjusted to control
breakthrough pain adequately.
In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same
as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora
120/166
4/6/2016
FDASafetyAlerts
delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.
Fentora (fentanyl buccal tablet) and the occurrence of serious adverse events
(posted 9/13/2007)
Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information
regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with
Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper
product substitution.
Topical Anesthetic Drugs for Cosmetic Procedures
(posted 2/6/2007)
FDA is issuing this advisory to alert consumers to the potential hazards of using skin numbing products, also known as topical anesthetics, for
cosmetic procedures. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream,
ointment, or gel. Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain and burning and
itching due to a variety of medical conditions. Applying topical anesthetics for a medical procedure is usually done in a doctors office by a trained
medical professional. However, FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health
professionals. Without this supervision, a patient may apply large amounts of topical anesthetics to their skin. This application can result in high levels
of these products in the blood causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.
Compounded topical anesthetic creams can cause serious reactions including seizures, irregular heartbeats and death
(posted 12/6/2006)
FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA
issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general
distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions
including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser
hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors'
offices.
ISMP has written on this topic on many occasions including our May 2005 issue of the ISMP Medication Safety Alert!, Community/Ambulatory Edition.
Advisory for Users of Diastat AcuDial Delivery Systems
(posted 4/3/2006)
The Food and Drug Administration is advising patients with epilepsy and their care givers of a potential hazard caused by cracks in the applicator tips
121/166
4/6/2016
FDASafetyAlerts
of Diastat AcuDial (diazepam rectal gel) delivery systems. These cracks can result in the leakage of gel during its application, which results in the
patient not getting enough of the medicine to control seizures. Caregivers for these patients are advised to call their local emergency response center
or 911 for help in any seizure emergency.
Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if
inadequately treated, can progress to a life-threatening condition in which seizures are continuous. The drug is typically administered by family
members or caregivers at home.
Adverse events with benzocaine sprays
(posted 2/13/2006)
The FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia,
associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing
mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways.On February
8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the
reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. ISMP
has written on this topic on many occasions including our Oct. 3, 2002 ISMP Medication Safety Alert!, an article in the Archives of Internal Medicine
(Reported Adverse Event Cases of Methemoglobinemia Associated With Benzocaine Products Thomas J. Moore; Christopher S. Walsh, PharmD; Michael
R. Cohen, RPh, MS, DSc Arch Intern Med.2004;164:1192-1196) as well as a recent press release.
Alert for Healthcare Professionals Nimodipine (marketed as Nimotop)
(posted 1/20/2006)
The FDA has requested that Bayer add a boxed warning to the nimodipine (Nimotop) labeling to warn about medication administration errors with
nimodipine. Nimodipine is approved for oral administration to improve neurological outcome after subarachnoid hemorrhage. When administered
intravenously or parenterally, it can cause serious adverse events, including death. Nimodipine must not be administered intravenously or by any
parenteral route. ISMP wrote about the dangers of nimodipine accidentally given intravenously in the August 25, 1999 Medication Safety Alert ! as well
as the July 25, 2005 edition.
Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names
(posted 1/11/2006)
The Food and Drug Administration (FDA) released a public health advisory cautioning consumers about filling prescriptions abroad, due to the possible
confusion of drugs with the same name but different active ingredients, an issue that ISMP has brought to light in the past. The advisory contains FDAgenerated lists of identical and very similar brand names used for different drugs marketed in the U.S. and overseas. The impetus for the FDAs
investigation was ISMPs January 27, 2005 newsletter article as well as subsequent Wall Street Journal coverage, which are both mentioned in the text.
The FDA also notes that the advisory complements ISMPs findings.
122/166
4/6/2016
FDASafetyAlerts
Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01295.html

Public Health Advisory: http://www.fda.gov/oc/opacom/reports/confusingnames.html
Avinza (morphine sulfate extended-release capsules)
(posted 11/3/2005)
Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to sections of the prescribing information to highlight and
strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or nonprescription medications containing alcohol while on Avinza therapy. Consumption of alcohol while taking AVINZA may result in the rapid release and
absorption of a potentially fatal dose of morphine.
Abbott Diabetes Care Blood Glucose Meters
(posted 10/27/2005)
FDA notified health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can
unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the
United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of
insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia.
Toprol-XL (metoprolol succinate) extended release tablets
(posted 9/26/2005)
AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol
succinate) extended release tablets, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc. There have also been reports of
medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals
Corporation. These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR,
and vice versa, some of them leading to adverse events.
Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland
(posted 9/17/2005)
FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture
Pharmacy Services, Inc. of Lanham, Maryland (CAPS) due to concerns regarding the sterility of these injectable products. CAPS distributed the affected
injectable products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. Gram negative rods have been identified in two lots of
Cardioplegia solution manufactured by CAPS.
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection) NovoLog (insulin aspart injection)
(posted 9/16/2005)
Until recently, the labeling for these two products was very similar, with the exception of the product names. To facilitate the dispensing of the correct
123/166
4/6/2016
FDASafetyAlerts
product, Novo Nordisk, Inc. has introduced color branded labeling for NovoLog Mix 70/30, a premixed insulin analog, and NovoLog, a rapid-acting
insulin analog. The previous box for NovoLog Mix 70/30 was white with a blue band. The packaging for NovoLog previously was also white with a blue
band. The current packaging is now white with an orange band.
Isotretinoin - Accutane and generic isotretinoin
(posted 8/15/2005)
FDA notified healthcare professionals and patients of the approval of a strengthened risk management program, called iPLEDGE, for Accutane and
generic isotretinoin. The strengthened program requires registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific
responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane.
Perrigo Infants Oral Drops Containing Enclosed Syringe
(posted 8/2/2005)
Perrigo and FDA notified healthcare professionals and consumers of the recall of all lots of concentrated infants drops that are packaged with a
dosing syringe bearing only a 1.6 mL mark containing:
1. acetaminophen,
2. acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or
3. dextromethorphan HBr, and pseudoephedrine HCl.
The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to
improper dosing, including overdosing.
Fentanyl Transdermal (Skin) Patch
(posted 7/15/2005)
FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects
from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients
using both the brand name product Duragesic and the generic product.
Duragesic (fentanyl transdermal system)
(posted 7/8/2005)
124/166
4/6/2016
FDASafetyAlerts
Janssen and FDA notified healthcare professionals of changes to the BOXED WARNING/WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE
AND ADMINISTRATION sections of the prescribing information for Duragesic.
Children's Tylenol Meltaways - 80 mg, Children's Tylenol Softchews - 80 mg, and Jr. Tylenol Meltaways - 160 mg
(posted 6/3/2005)
McNeil Specialty Pharmaceuticals and FDA notified consumers and healthcare professionals about a nationwide recall of all lots and all flavors of
Children's TYLENOL Meltaways 80 mg, Children's TYLENOL SoftChews 80mg, and Junior TYLENOL Meltaways 160mg. The recall addresses issues
regarding the design of the blister package, information on the package, and bottle cartons for the products that may be confusing and lead to
improper dosing, including overdosing.
MEDICAL DEVICES
Perseus A500 Anesthesia Workstation by Draeger: Class I Recall
(posted 12/23/2015)
Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down
unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. This could cause patients to
suffer serious adverse health consequences, including injury or death. The recall includes all Draeger Perseus A500 anesthesia workstations
manufactured from June 1, 2013 to September 30, 2015 with distribution dates of February 1, 2015 to September 30, 2015. See the FDA Recall Notice
for a link to a list of affected serial numbers.
The company has received one report of this issue occurring, with no injuries and no deaths.
The Draeger Perseus A500 Anesthesia Workstation provides anesthesia and breathing support for children and adults. This medical device is used in
hospitals.
Draeger sent an urgent field safety notice to all customers with affected devices on November 10, 2015, informing them of this issue. The letter
indicates that the power switch of affected workstations must be replaced. A Draeger service representative will contact customers to schedule a
replacement, free of charge. Until the replacement takes place, Draeger recommends that users operate affected Perseus A500 workstations under
continuous supervision. Customers with questions are instructed to call Draeger technical support: 1-800-543-5047.
Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy
(posted 8/27/2015)
An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the
patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and
reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or
125/166
4/6/2016
FDASafetyAlerts
interruption of therapy and can lead to serious patient injury or death. CareFusion has received 108 reports of the issue occurring. There have been no
reports of permanent injury or death.
A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patients body in controlled amounts. They are
widely used in clinical settings such as hospitals, nursing homes, and in the home.
The firm informed customers of the problem in a July 20, 2015 letter and indicated the company will contact all affected customers within 60 days to
schedule a repair. Until the affected units can be repaired, CareFusion recommends customers take the following actions if the 351.6740 error code
occurs:
Consider using another syringe pump.
Use an IV syringe push if clinically appropriate.
Clearly mark and sequester the Alaris Syringe pump that exhibited the channel error code.
Notify CareFusion Support Center at 888-562-6018 or supportcenter@carefusion.com.
Customers should establish back-up plans, in case of an infusion pump failure, that allow clinicians to obtain a working infusion pump and infusion
tubing quickly.
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under
Delivery of Fluid by an Infusion Pump
(posted 8/27/2015)
Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause
patient injury or death. See the Recall Notice for a list of part and lot numbers.
The Alaris Medley Large Volume Pump (LVP) is an infusion pump used to deliver fluids such as nutrients and medications into a patients body in
controlled amounts. The frame membranes are part of the pump that prevents fluids from leaking into internal components. Infusion pumps are
widely used in clinical settings such as hospitals, nursing homes, and in the home.
On May 21, 2015, Elite Biomedical Solutions sent their customers a Product Advisory Notices. On June 3, 2015, the firm sent their customers an
Urgent: Medical Device Part Recall letters. And on June 12, 2015, a press release was issued via ECRI (Emergency Care Research Institute) to all
hospitals in the US. In these communications, customers were instructed to take the following actions:
Immediately examine your inventory and quarantine the affected product.
If the affected product was further distributed, please identify your customers and notify them at once of this product recall.
126/166
4/6/2016
FDASafetyAlerts
Regardless of whether you have the affected product, complete the Reply Form as soon as possible and return it to Elite Biomedical Solutions.
Elite Biomedical Solutions will provide your facility with a replacement part for each affected frame membrane, along with a label for product return.
Forward a copy of the letter to any facility to which you have further distributed affected product.
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities
(posted 7/31/2015)
The FDA, the U.S. Department of Homeland Securitys Industrial Control Systems Cyber Emergency Response Team (ICS-CERT), and Hospira are aware
of cybersecurity vulnerabilities associated with the Symbiq Infusion System. FDA strongly encourages health care facilities transition to alternative
infusion systems, and discontinue use of these pumps.
Hospira and an independent researcher confirmed that Hospiras Symbiq Infusion System could be accessed remotely through a hospitals network.
This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of
critical patient therapies. The FDA and Hospira are currently not aware of any patient adverse events or unauthorized access of a Symbiq Infusion
System in a health care setting.
Hospira has discontinued the manufacture and distribution of the Symbiq Infusion System, due to unrelated issues, and is working with customers to
transition to alternative systems. However, due to recent cybersecurity concerns, the FDA strongly encourages health care facilities to begin
transitioning to alternative infusion systems as soon as possible.
While these infusion pumps are currently not available for purchase through Hospira, the FDA is aware that the Symbiq Infusion System is potentially
available for purchase from third parties not associated with Hospira. The FDA strongly discourages the purchase of the Symbiq Infusion System from
these parties.
The FDA is actively investigating the situation based on current information. If new information becomes available about patient risks and any
additional steps users should take, the FDA will communicate such information publicly. For additional information, see the FDA Safety
Communication.
The Hospira Symbiq Infusion System is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient
population.
It is primarily used in hospitals, or other acute and non-acute health care facilities, such as nursing homes and outpatient care centers. This infusion
system can communicate with a Hospital Information System (HIS) via a wired or wireless connection over facility network infrastructures.
While transitioning to an alternative infusion system, consider taking the following steps to reduce the risk of unauthorized system access:
127/166
4/6/2016
FDASafetyAlerts
Disconnect the affected product from the network.

CAUTION: Disconnecting the affected product from the network will have operational impacts. Disconnecting the device will require drug libraries to
be updated manually. Manual updates to each pump can be labor intensive and prone to entry error.
Ensure that unused ports are closed, including Port 20/FTP and Port 23/TELNET.
Monitor and log all network traffic attempting to reach the affected product via Port 20/FTP, Port 23/TELNET and Port 8443. Contact Hospiras
technical support to change the default password used to access Port 8443 or close it.
FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation
(posted 7/1/2015)
FDA is providing notification of a Class I recall of FLOW-i Anesthesia Systems by Maquet. The firm has received several complaints where patient
cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient
cassette from its mount when users perform a change of system. This may cause anesthesia gas to leak and could prevent the ventilator from
providing breathing support if not corrected immediately.
The firm has received 10 reports this device has malfunctioned; no injuries or deathshave been reported.
The Flow-i Anesthesia System administers anesthesia while providing ventilation to patients with no or limited ability to breathe. The system is used in
hospitals, for use in a range of patients from neonatal to adult.
A Maquet Service representative will contact consignees to arrange replacement of the FLOW-i Anesthesia System patient cassette locking device.
For questions regarding this field action, please contact a Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (Press
option 3, followed by option 1 and then option 1 again), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EST.
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities
(posted 5/13/2015)
The FDA and Hospira have become aware of security vulnerabilities in Hospiras LifeCare PCA3 and PCA5 Infusion Pump Systems. An independent
researcher has released information about these vulnerabilities, including software codes, which, if exploited, could allow an unauthorized user to
interfere with the pumps functioning. An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers,
which could lead to over- or under-infusion of critical therapies. The FDA is not aware of any patient adverse events or unauthorized device access
related to these vulnerabilities.
The FDA is actively investigating the situation based on current information and close engagement with Hospira and the Department of Homeland
128/166
4/6/2016
FDASafetyAlerts
Security. As new information becomes available about patient risks and any additional steps users should take to secure these devices, the FDA will
communicate publicly.
The Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems are computerized infusion pumps designed for the continuous delivery of anesthetic or
therapeutic drugs. These systems can be programmed remotely through a health care facilitys Ethernet or wireless network.
Recommendations for Health Care Facilities:
Follow the recommendations from the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) of the U.S.Department of Homeland in
the May 13, 2015 Advisory Hospira LifeCare PCA Infusion System Vulnerabilities (Update A).
Perform a risk assessment by examining the specific clinical use of the Hospira LifeCare PCA Infusion Pump System in your organizations environment
to identify any potential impacts of the identified vulnerabilities.
Look for and follow risk mitigation strategies outlined in an upcoming letter from Hospira to its customers. Customers can access the instructions and
other risk mitigation measures via Hospiras Advanced Knowledge Center.
Follow the good cybersecurity hygiene practices outlined in the FDA Safety Communication Cybersecurity for Medical Devices and Hospital Networks,
posted in June 2013
Refer to the FDA Safety Alert for detailed recommendations including a link to the ICS-CERT
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure
(posted 3/6/2015)
The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in
situations that should trigger it. It is possible for a long delay before a health care professional becomes aware of the need to restore therapy. For
patients receiving critical intravenous medication, there is a risk of injury or death resulting from this prolonged interruption in therapy. See the Recall
Notice for a listing of products affected by this recall.
Manufacturing and distribution dates: July 2012 to May 2014. Date recall initiated: May 28, 2014.
Stericycle, Inc. sent two Urgent Medical Device Correction letters dated July 2, 2014 and July 16, 2014 to customers. The letters notified customers that
Hospira would contact them regarding the completion of an audible alarm test and will replace any alarm assemblies that fail to audible alarm test.
Hospira has contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response tracking, returns, effectiveness checks and
destruction of product returns. Questions should be directed to Stericycle at 888-912-7350 (Monday - Friday, 8:00 AM - 5:00 PM ET).
129/166
4/6/2016
FDASafetyAlerts
Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled
(posted 2/11/2015)
A manufacturing error caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the
incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs. See the FDA Class I Recall Notice for a
complete list of affected model and lot numbers.
Depending upon the size of these clots, there is the possibility of serious patient injury or death.
The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or
feet. The systems have two balloons that are inflated to isolate a clot. Medication is released between the balloons to reduce the size of or dissolve the
clot so it can be removed. These devices are used by health care providers.
Customers were sent an urgent product recall letter dated December 15, 2014. The letter identified the affected product and actions for customers.
Customers should discontinue the use of the Trellis 6 and 8 infusion systems and return it to Covidien along with a response form included in the
letter. Customers with questions should contact their Covidien sales rep or Covidien Service at 1-800-716-6700.
Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use) - Falsely Low INR Test Results
(posted 1/9/2015)
A recall has been issued for Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use). The
Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result
obtained using a laboratory INR method. Incorrect results can also occur if a patient has certain medical conditions. These conditions include, anemia,
conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling
for performing the test are not followed. (See Healthcare Professional letter or Patient letter).
Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death. Alere received 18,924 reports of
incidents in which the device has malfunctioned, including 14 serious injuries. According to the firm, all affected devices may fail. This recall is not
expected to cause a device shortage.
GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity
(posted 11/5/2014)
The power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be
delayed if a backup power supply is not used.
Hospira received a total of 20 reported incidents including one report of smoke and found that the GemStar Infusion Pump was operating on battery
power while connected to the 3VDC power supply. There were no reports of injuries or death.
130/166
4/6/2016
FDASafetyAlerts
The firm noted that all 13,002 units distributed worldwide, with 5,687 of those units distributed in the U.S., may fail. The use of the recalled devices
may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart
rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death. In oxygen-rich environments, an
electric shock or spark from a malfunctioning pump could cause a fire.
The GemStar Supply is an accessory that provides power to the GemStar Infusion Pump. The power supply converts alternating current (AC) voltage of
120 or 240V to Direct Current (DC) voltage of 3.3 Volts. Hospira GemStar Infusion Pumps are used to deliver controlled amounts of fluids including
medicines, blood, blood products, nutritional foods, and other mixtures, into a patients body in controlled amounts. Hospira Gemstar Infusion Pumps
are used in hospitals, for outpatient care, and for home care.
Remove the power supply from service. If you (or a potential user) believe that the power supply is damaged for any reason. Contact Hospira Global
Complaints at 1-800-441-4100 to report the concern.
Hospira sent an Urgent Medical Device Correction letter dated February 3, 2014 to all direct customers. The letter outlined the problem and the steps
to be taken.
Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms
(posted 5/22/2014)
FDA notified health professionals of a Class I Recall due to software failures when using ABACUS TPN calculation software. If any of these failures were
to occur, patients may be at risk for toxic or overdose symptoms. Symptoms may be non-specific and include nausea, vomiting, dizziness or fatigue.
Some more severe symptoms include a problem with the rate or rhythm of the heartbeat (cardiac arrhythmia), an abnormal buildup of fluid in the air
sacs of the lungs, which leads to shortness of breath (pulmonary edema), congestive heart failure and seizures. A fatal outcome is possible, especially
with the high risk population.
The affected software was manufactured from May 17, 2006 through May 28, 2013 and distributed from May 17, 2006 through March 17, 2014.
Affected product codes can be found in the FDA Recall Notice.
ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN
formulas. TPN is used to meet the nutritional needs of patients who cannot eat or drink by mouth and is used in the hospital or in the home by a
licensed health care professional.
On April 21, 2014, Baxter sent an Urgent Device Correction letter to all affected customers. Baxters letter directed customers to contact Baxter to
ensure that the ABACUS software is configured correctly. Customers with a software version earlier than 3.1 will have software version 3.1 installed
that addresses the issues in the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper
ABACUS configuration in the customers facilities.
131/166
4/6/2016
FDASafetyAlerts
Baxter also requested that its customers take specific actions, which can be found in the FDA Recall Notice.
Health care professionals: For questions about the actions to be taken, contact Baxter Technical Support at 1-800-678-2292, Monday through Friday,
6 am - 5 pm, Mountain Time or by email at COtechsupport@baxter.com. For questions about the recall, contact Baxter at 303-617-2242.
Patients having this procedure at home: For questions about this recall, contact your home health care agency or doctor.
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion
(posted 5/21/2014)
CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump may have a software failure where the pump module will not
properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. This issue does not impact the Delay For Option. The software
failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. See the FDA recall notice for more
information.
Infusion start times earlier or later than intended could result in serious injury or death.
The Alaris Pump Model 8100 is a large volume infusion pump. The affected products were manufactured from February 6, 2014 to April 8, 2014 and
distributed from February 7, 2014 through April 7, 2014. See the FDA recall notice for a listing of the affected serial numbers.
The firm recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. CareFusion will contact all
affected customers to schedule the installation of software version 9.1.17. Do NOT use the Alaris Pump module Delay Until option. Do NOT use the
Multidose feature.
As an interim guidance, customers may update their dataset to disable both Delay Options and/or Multidose across all Profiles to prevent the use of
Delay Until option and/or Multidose feature. These are shared configurations with the Alaris Syringe module and if disabled would prevent use of
these features with the Alaris Syringe module as well.
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory
(posted 5/7/2014)
Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional
Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere has received nine serious adverse
event reports, three of which described bleeding associated with patient deaths.
The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local
132/166
4/6/2016
FDASafetyAlerts
laboratory plasma INR test. Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately
low INR result.
Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The
voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.
Healthcare professionals should immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips and use an alternative method to perform
PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a
different manufacturer.
Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy
(posted 5/2/2014)
Baxter has received over 3500 reports of System Error 322 Link Switch Error (low) incidents in which the device has malfunctioned, including nine
severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically
closed. A System Error 322 may lead to an interruption or delay in therapy.
If the System 322 occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual 322 alarm). This
requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.
The use of affected product may cause serious adverse health consequences, including death.
Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.
Customers who encounter a System Error 322 are instructed to:
1. Turn the pump off by pressing the ON/OFF Key, then
2. Turn the pump back on by pressing the ON/OFF key in order to clear the alarm.
Clinicians will need to reprogram the infusion after the pump is turned back on. If the alarm cannot be cleared using the above instructions, the device
should be removed from use and sent to the facilitys biomedical engineering department. If the System Error 322 reoccurs, the pump may need to be
inspected and serviced by Baxter Healthcare Corporation. Baxter Healthcare can be contacted at 1-800-356-3454 (choose option 1) Monday through
Friday, 7 am to 7 pm, Eastern Time.
Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies
(posted 5/2/2014)
Hospira received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps.
133/166
4/6/2016
FDASafetyAlerts
When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. If the door
assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. If the door cannot be closed, the
pump cannot be used which can result in a delay of therapy.
Use of these affected products may cause serious adverse health consequences, including death.
Affected Abbott Acclaim Infusion Pumps, list Number 12032 were manufactured from February 1998 to November 1998 and distributed from
September 1998 through February 2004. Affected Hospira Acclaim Encore infusion pumps list Number 12237 were manufactured from February 1997
to February 2010 and distributed from July 1999 through November 2013.
Hospira recommends that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks, prior to programming a therapy,
by following the steps outlined below:
1. After inserting the tubing (with the roller clamp closed) and closing the door handle against the infusion pump, check that the door is fully closed.
If a pump has a door that does not close properly, and a gap or separation exists between the completely closed door and the pump itself, remove the
pump from clinical service and call Hospira.
For pumps where the door closes correctly, proceed to Step 2.
2. For pumps with the door closing correctly, and a gap or separation does not exist between the completely closed door and the pump itself, check
that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.
If free flow is detected, close the roller clamp, remove the pump from clinical service and call Hospira.
3. If no issues are found through steps 1 and 2, the pump is deemed acceptable for use. Additionally, please take the following actions related to this
safety notification:
Ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.
Complete the reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. Contact
Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to obtain additional copies of the reply form, if needed.
If you have further distributed the Hospira/Abbott Acclaim Encore infusion pumps, please notify your customers who may have received these infusion
pumps from you and ask them to contact Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to receive a reply form.
134/166
4/6/2016
FDASafetyAlerts
Product Correction:
After following the instructions above, if you determine that a pump has a door that does not close correctly or if free flow is detected while the
administration set is in the pump with the door closed, close the roller clamp, remove the pump from clinical service and call Hospira.
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up
(posted 5/2/2014)
Hospira, Inc., announced today a nationwide medical device correction of the GemStar Docking Station (list number 13075), used in conjunction with
the GemStar infusion pump. When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150) the potential
exists for the GemStar Phase 3 pump to fail to power up while connected to the docking station. When a GemStar Phase 3 (List 13000, 13100 or
13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used in conjunction with both a docking station and an external battery pack
accessory (List 13073), there is a possibility that the GemStar pump will display error code 11/003 and give an audible alarm, indicating excessive
input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage
input, the pump will stop the infusion. This will trigger an audible alarm and the device will display alarm code 11/003.
If a GemStar fails to power up or the 11/003 error code stops an infusion, a delay of therapy may occur. A delay or interruption in therapy has a worst
case potential to result in significant injury or death.
The GemStar Docking Station is a separately sold accessory to the GemStar infusion pump and provides an alternate power source to the GemStar
pump. The products impacted by these issues are identified in a table in the Firm Press Release.
Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies.
Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in/of therapy could result in serious
injury or death. There is no need to return the GemStar Docking Station at this time and Hospira recommends that users take the following actions:
1.To avoid a failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power
up.
2.To mitigate the potential for an 11/003 error code, remove the external battery pack accessory (List 13073) from the docking station and pump
prior to installing the pump into the Docking Station. If you use a docking station in conjunction with an external battery pack accessory (List 13073),
this practice sould not continue. Please contact Hospira to discuss an appropriate alternative option.
Users who experience a failure to power up or an 11/003 error code should report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm
CT) or email ProductComplaintsPP@hospira.com. For additional assistance or to obtain a copy of the Urgent Medical Device Correction letter and/or a
reply form, please contact Stericycle at 1-866-792-5451 (M-F, 8am-5pm ET).
135/166
4/6/2016
FDASafetyAlerts
GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results
(posted 4/29/2014)
The FDA is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report
incorrect blood glucose levels.
During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of
products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of a quality
system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels.
GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips. Shastas GenStrips are
advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini).
Discontinue use of GenStrip Blood Glucose Test Strips. FDA recommends the use of alternative glucose test strips that are designed for use with the
LifeScan OneTouch family of glucose meters.
Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products
(posted 3/18/2014)
Hospira identified that an incorrect set component was
supplied and used during the manufacturing process of the impacted product lots. The Hemostat Dual Channel Plum Set is designed to administer
blood and blood products via the Plum infusion pump. If the Plum infusion pump is used with the affected product, the blood product will be delivered
at its intended dosage and there is no risk of over-delivery. If the affected product is removed from the Plum infusion pump and used in a gravity
infusion, there is a risk that over-delivery may occur. Over-delivery of blood products in the populations at greatest risk (e.g. neonates, patients with
heart and/or kidney failure, and other patients with conditions associated with susceptibility to volume overload) may result in injuries that require
medical intervention. These injuries are expected to fully resolve with medical intervention.
The blood sets impacted by the recall (list number 11241-03, lot numbers 28005-5H and 34100-5H)were distributed to U.S. healthcare and veterinary
facilities from May 2013 through Dec. 2013.
Customers should check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this
product in their organizations of this notification. Affected product should be returned to Stericycle.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA''s
MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
136/166
4/6/2016
FDASafetyAlerts
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit
by fax to 1-800-FDA-0178
[03/18/2014 Press Release- Hospira]
FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results
(posted 3/16/2014)
Abbott is conducting a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle
test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce mistakenly low blood glucose results.
BACKGROUND: FreeStyle and FreeStyle Flash Blood Glucose Meters have not been in production since 2010. Abbott began notifying users on Feb. 19,
2014, immediately after the issue was discovered.
RECOMMENDATION: Abbott recommends the following actions for people with meters affected by this recall:
Immediately contact Abbott Diabetes Care at 1-888-345-5364 to obtain a replacement meter.
If the only meter available to you is an affected meter, continue to test your blood glucose as recommend by your doctor while you wait for your
replacement meter. When using an affected meter, follow the precautions and recommendations in the press release.
If you have access to an alternative glucose meter, immediately discontinue use of the affected meter and take the necessary steps to continue to
monitor your blood sugar with the alternative meter.
For users of the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter, refer to the Abbott recommended actions at
https://www.abbottdiabetescare.com/press-room/2014/2014-b.html
Glucose Meters Recalled by Nipro Diagnostics
(posted 1/8/2014)
Nipro Diagnostics initiated a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed
both in the United States and outside the United States.
The company determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect factory-set unit of measure that
displays the glucose result in mmoi/L rather than mg/dl. If a consumer were not to notice the incorrect unit of measure, it is possible that the meter
result could be read as a lower than expected blood glucose result.
There are 501 affected TRUEbalance meters and 105 affected TRUEtrack meters that were distributed in the United States from September 2008 to May
137/166
4/6/2016
FDASafetyAlerts
2013. The company is sending notifications to pharmacies, durable medical equipment providers, mail order companies and distributors where the
TRUEbalance and TRUEtrack meters are recommended or sold in the United States.
Consumers who have a TRUEbalance or TRUEtrack meter should: 1) Check to confirm if they have an affected TRUEbalance or TRUEtrack meter by
obtaining the serial number from the serial number label on the back of the meter and visiting www.NiproDiagnostics.com/product-notice or by
calling Stericycle toll-free at 1-866-236-4518; and 2) If the consumer has an affected TRUEbalance or TRUEtrack meter, please call Stericycle to verify
serial number, and to expedite return and replacement of these affected TRUEbalance and TRUEtrack meters at no charge.
Consumers may continue to test blood glucose using any other Nipro Diagnostics blood glucose meter not included in this recall while waiting for
their replacement meter to arrive. Only use test strips that are intended for use with their blood glucose meter.
Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift
(posted 11/25/2013)
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test or
resulting in an error being reported during device setup or infusion (refer to Recall Notice for list of errors).
A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and
invoke visual and audible warnings to the user. This issue may also result in the pump shutting down.
Potential risks include a delay/interruption in therapy or over-infusion, which have a worst case potential to result in significant injury or death.
The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is
required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general
I.V. fluids, medications, nutritional foods and blood/blood products.
All GemStar Infusion Pumps (Models 13000, 13100, 13150, 13086, 13087, 13088) that were either manufactured or had a pressure sensor replaced
during servicing of the pump since January 1, 2009 could be affected.
Immediately perform proximal and distal occlusion tests as defined in the GemStar Technical Service Manual. If the device fails either of the tests,
remove it from clinical service. Contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM Central Standard Time) to report the issue
and arrange for the return of the device for recalibration. Add the performance of a proximal and distal occlusion test to your yearly GemStar
maintenance schedule.
Customers should consider the use of an alternative pump, particularly in patients in which a delay or interruption in therapy or an over-infusion could
result in significant injury or death.
138/166
4/6/2016
FDASafetyAlerts
MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion
(posted 10/23/2013)
FDA and Codman & Shurtleff, Inc. notified healthcare professionals of the class 1 recall of MedStream Programmable Pump and MedStream Refill Kit
due to air in the pump reservoir which may release a higher dosage of drug than expected, leading to drug overdose. This product may cause serious
adverse health consequences, including low blood pressure (hypotension), an abnormally slow heart rate (bradycardia), loss of consciousness, and/or
death.
The MedStream Programmable Infusion Pump is an implanted drug delivery system used in the US for the chronic delivery of Baclofen to treat muscle
symptoms and used in Europe, Middle East, and Africa (EMEA) for the chronic delivery of Morphine or Baclofen. Refill kits are used in filling and refilling of the MedStream pump reservoir. On August 13, 2013, Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice Letter to US and
International customers. The affected products were manufactured from March 2009 to September 2012 and distributed from January 08, 2010 to July
19, 2013. Please refer to Class 1 Recall Notice for affected Product Codes and link to Letter.
Contact Codman Representative or Codman Neuro Clinical Support at 1-800-660-2660 for questions about the recall. Report any malfunctions or
adverse events related to the MedStream Programmable Infusion Pumps and refill kits to 1-866-491-0974 (choose option 2). Health care providers
and consumers may report adverse events or quality problems experienced with the use of any Main Street products to the FDAs MedWatch Adverse
Event Reporting program:
Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results
(posted 10/17/2013)
Nephron Pharmaceuticals initiated a voluntary recall, at the retail level, of ten lots of product due to results from an internal monitoring process. NPC
performs aseptic process simulation as part of an internal processes to assure product quality. All of the lots listed above met and passed NPCs
quality specifications at the time of manufacture. In accordance with published guidance regarding aseptic processing simulation from the FDA, NPC
has initiated this recall as a precautionary measure.
The affected product is identified as Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25) and
lots A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A
NPC is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may
have that is included in this recall.
Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label,
Filled Volume And Wrapper
(posted 8/20/2013)
Covidien announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. This recall is being conducted due to the
139/166
4/6/2016
FDASafetyAlerts
risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled as either
sodium chloride flush or heparin lock flush. Some of these syringes have the mismatched syringe tip cap, syringe label, filled volume and wrapper.
However, for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume and wrapper, there are no visual cues for the
clinician to identify the problematic products. If non-sterile fluid is administered there is a health risk of life-threatening infection to the blood stream
or other areas. Also if the clinician uses the heparin lock flush syringe containing only water on peripheral or venous catheters, the patency of the
intravascular device may not be maintained and clotting may occur. This could result in non-functional intravenous access requiring the device to be
replaced.
Only Monoject prefill flush syringes from the lot numbers listed are affected by this action (see Firm Press Release for list of affected lot numbers). The
lot numbers can be found on the shipper case, carton and individual syringes. Customers are required to identify, segregate and return any affected
products in their inventory.
Customers have been notified of this issue by letter dated August 16, 2013. To return the affected product for credit, please contact our Customer
Service group at 1-800-962-9888.
Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit: Class
I Recall - Potential for Incorrect Recommended Infusion Rate
(posted 8/12/2013)
FDA notified healthcare professionals of a Class I recall of the Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145
Dose Error Reduction System (DERS) Drug Library Kit. The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for
the pump infusion rate during the initial infusion setup. This is due to a specific key sequence when the override feature of the DERS drug limits is
activated. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value. This can
cause serious adverse health consequences, including death.
These products were manufactured from Oct. 1, 2011 through June 27, 2013 and distributed from Oct. 6, 2011 through June 28, 2013. Refer to the
the FDA Recall Notice for a listing of affected part numbers.
The MRidium 3860+ Infusion pumps are intended for general hospital or clinical use by medical professionals whenever it is required to infuse
patients with fluids and/or medications into the vein (intravenous) or through the artery (intra-arterial) before, during or after Magnetic Resonance
Imagining (MRI) scans. The MRidium 1145 Dose Reduction System (DERS) drug library kit is an accessory intended for use with the MRidium 3860+
Infusion Pump System.
Iradimed Corporation notified its customers by phone and on July 1, 2013 they sent an URGENT MEDICAL DEVICE RECALL NOTICE to all customers. The
notice described the product, problem and actions to be taken. Customers were instructed to identify the MRidium 3860+ Infusion Pumps which have
the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time. However, if the DERS Library card is
installed, remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided in the URGENT MEDICAL DEVICE RECALL NOTICE.
140/166
4/6/2016
FDASafetyAlerts
The product will be repaired (reconditioned) by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be
seen during the 3860+ Pump''s power on cycle.
CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall - Potential Loss of Communication Between Main
Processor and Keyboard
(posted 8/7/2013)
CareFusion has reported that if the Alaris PC unit model 8015 voltage is 1.4 volts, rather than the 1.8 volts required for operation, the device could
potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. A device malfunction can result in the
sudden unintended discontinuation of medications.
When the Alaris PC unit model 8015 experiences a communication error, the unit will display either a "SYSTEM ERROR" or "CHANNEL DISCONNECTED"
error message. During the communication error, the programmed infusion(s) will run as previously programmed; however no further key presses on
the Alaris PC unit have an effect on the system, including "PAUSE" and "SILENCE" keys. The user may terminate all infusions by pressing the "SYSTEM
ON" key. Termination of an infusion could result in serious injury or death.
The Alaris PC unit (model 8015) is part of the Alaris electronic infusion pump. An electronic infusion pump delivers controlled amounts of medications
or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
On June 17, 2013, CareFusion issued an Urgent Medical Device Recall to all affected customers with required actions for users. A CareFusion
representative will contact all affected customers within 60 days to provide an update to correct the voltage on the keyboard processor. CareFusion
does not require customers to return their devices.
MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor
(posted 7/23/2013)
The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The Fill Level Sensor is intended to
measure the contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may cause the pumps low reservoir alarm, normally set at 3
ml, to sound too early or too late.
These affected products were distributed from July, 2009 through June, 2013 and include Models 91-4200US 20 ml pump, .91-4201US 40 ml pump,
91-4200 20 ml pump, 91-4201 40 ml pump
On June 07, 2013, Codman issued a Medical Device Corrections Notice1 2 to consignees to inform them of a potential problem with the MedStream
Programmable Infusion Pump. The notice directed clinicians to evaluate the accuracy of the Fill Level Sensor, during each patients next scheduled refill
session, or sooner if the patient is symptomatic. The firm provided a worksheet (step by step instructions) to identify pumps with a miscalibrated Fill
141/166
4/6/2016
FDASafetyAlerts
Level Sensor and management recommendations for patients with affected devices. No action for physicians is required beyond the recommendations
provided in the Medical Device Corrections Notification letter.
Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed Through Failure, Failure of Priming Bolus, and Catheter
Occlusion
(posted 6/28/2013)
In June 2013, Medtronic, Inc. initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System.
The Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls. The fourth notification is an update to a 2011
action related to pump refill which was previously classified by the FDA as a Class I recall.
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Failure of Priming Bolus
Reason for Recall: The SynchroMed Implantable Infusion Pumps are being recalled because of the unintended delivery of drugs during the priming
bolus procedure. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF)
followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious
medical illness such as respiratory depression, coma or death.
Products: SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size).
Medtronic recommends healthcare professionals continue using the priming bolus procedure to ensure therapy is initiated while a patient is under
medical supervision. For Complete list of recommendations please see Class 1 Recall Notice.
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Feed Through Failure
Reason for Recall: There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough
may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy. This may result in the return of underlying
symptoms and/or withdrawal symptoms. Use of this recalled product may result in serious adverse health consequences, including death.
Products: SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size).
Medtronic Sutureless Connector Intrathecal Catheter Products Catheter Occlusion
Reason for Recall: The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the
blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all
142/166
4/6/2016
FDASafetyAlerts
unused products that were manufactured with the previous design. Medtronic recommends the previous design of Sutureless Connector Intrathecal
Catheter Products no longer be used due to greater potential for misalignment and subsequent occlusion. This product may cause serious adverse
health consequences, including drug under dose, loss of symptom relief, drug withdrawal symptoms caused by the lack of drug delivery to the
Intrathecal space, and/or death.
Products: Sutureless Connector Intrathecal Catheters, Models 8709SC, 8731SC
Sutureless Revision Kits, Models 8596SC, 8578
Medtronic does not recommend the use of any affected devices with the old design.
SynchroMed Implantable Infusion Pump Refill Procedure Safety Update
Medtronic is distributing a revised Clinician Refill Reference Card with information about the pump refill procedure for the SynchroMed Implantable
Infusion System. This is a continuation of a 2011 notification that was previously classified as a Class I recall. The revised reference card reflects new
product labeling approved by the FDA to help healthcare professionals reduce the potential for a pocket fill during the SynchroMed pump refill
procedure. A pocket fill is the inadvertent injection during a refill procedure of all or some of the prescribed drug into the patient''s subcutaneous
tissue, which includes the pump pocket (area under the skin where the pump is placed), instead of into the pump.
Medtronic''s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin.
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed
drugs to a specific site inside the patients body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal,
Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and
severe spasticity. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories.
The Sutureless Connector Intrathecal Catheter and Revision Kits are accessories to an implanted infusion system designed to store and deliver
parenteral drugs to the Intrathecal space. The implanted infusion system components consist of a Medtronic SynchroMed implantable drug infusion
pump and an Intrathecal Catheter. The Sutureless Revision Kit is used when a pump connector for an Intrathecal Catheter is required.
These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using
the SynchroMed Implantable Infusion System. Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug
therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose.
Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of
symptoms or hear a device alarm, they should contact their physician immediately.
Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates
(posted 6/12/2013)
143/166
4/6/2016
FDASafetyAlerts
FDA and Symbios are informing the public of a recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control
components assembled prior to July 2012. The affected products may have excessively high flow rates. As a result, medications could be delivered too
quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness, including
seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications.
The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a
local anesthetic medication. The medication is delivered slowly through tubes from the balloon to the surgical site.
Please see the Recall Notice with listing of all the lot numbers affected. Customers who have purchased the affected devices were notified by letter
dated May 10, 2013 about the problem and follow-up letters were sent on May 14, 2013 and May 30, 2013 notifying customers of additional recalled
lots. Symbios is working to secure all affected product and have it returned.
Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result
(posted 5/20/2013)
Abbott initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose Meters in the United States. At extremely high blood glucose levels of 1024
mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the
measured result. Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur,
they are a serious health risk that requires immediate medical attention.
The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood
sugar levels. On April 15, 2013, Abbott Diabetes Care sent an Urgent Product Recall letter to all its affected customers. The FreeStyle InsuLinx Blood
Glucose Meters were distributed from April 18, 2012 through April 1, 2013.
Consumers who are using the FreeStyle InsuLinx Meter should immediately take one of the following actions to address this issue with your meter:
Access a software update to install on your meter to resolve the issue at: www.freestyleinsulinx.com/swupdate. The software update will allow you to
maintain settings and historical data on your meter.
Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no
charge. Replacements are available, and Abbott will send a meter to you immediately upon request.
Healthcare professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits are advised to immediately discontinue dispensing them to your
patients, and to arrange for product return and replacement, call Abbott Diabetes Care customer service at 1-866-723-2697.
Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage
(posted 4/29/2013)
144/166
4/6/2016
FDASafetyAlerts
Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models 13000, 13100, 13150, 13086, 13087, 13088.
When the GemStar Lithium battery voltage level drops below 2.4 volts, an "11/004" error is displayed and the device is rendered inoperable. This
failure mode results in a delay/interruption of therapy. Additionally, infusion settings and event history logs will be erased as a result of this device
malfunction.
The severity of the clinical impact, due to the delay/interruption in therapy, is dependent upon the underlying condition of the patient and the
treatment being prescribed. A delay/interruption in therapy has a worst case potential to result in a significant injury or death.
The affected units were manufactured and distributed between February 1999 and April 2013.
The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is
required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general
I.V. fluids, medications, nutritional foods and blood/blood products.
The customer notification letter stated that lithium batteries that are older than three (3) years should be replaced. Contact the Hospira Advanced
Knowledge Center at 1-800-241-4002, option 4, 24 hours a day/7 days a week, to determine if your battery needs to be replaced and if necessary to
arrange for the return of your device to perform battery replacement. Facilities that periodically retrieve the history logs from their GemStar Infusion
System should consider retrieving them more often to reduce the amount of history log information that would be lost should this failure occur.
Customers should consider the use of an alternative product, particularly in patients in which a delay/interruption in therapy could result in significant
injury or death.
LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels
(posted 4/23/2013)
At extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message
EXTREME HIGH GLUCOSE above 600 mg/dL as intended. When turned back on, the meter enters the Set-Up mode and requires the user to confirm
the date and time settings before being able to test again. However, if the glucose level is still measuring1024 mg/dL or above when testing, the
meter will shut down again.
The OneTouch Verio IQ Blood Glucose Meter is an over-the counter single-use device intended to be used by a patient outside of a health care facility
as an aid to monitor the effectiveness of diabetes control measures sugar (glucose) in blood drawn from the fingertips. All OneTouch Verio IQ Blood
Glucose Meters are being recalled and were distributed from December 14, 2011 through March 7, 2013.
If the OneTouch Verio IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, blood glucose may be extremely high, and you
should call your health care professional. Call LifeScan Customer Service at 1-800-717-0276 for support.
145/166
4/6/2016
FDASafetyAlerts
CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall - Communication Error When Attached to EtCO2 or SpO2 Modules
(posted 4/22/2013)
CareFusion Corporation has received reports of customers experiencing a communication error on the Alaris PC unit (model 8015) with software
version 9.12 when attached to the Alaris EtCO2 module (model 8300) or the Alaris SpO2 module (models 8210 and 8220).The firm issued a recall
notification letter informing affected customers. While toggling between the Alaris EtCO2 Main Screen, displaying the Capnography waveform, and the
EtCO2 Limits screen, the Alaris PC unit may experience a communication error. The communication error can also be experienced while toggling
between the Alaris SpO2 Main Screen, displaying the Pleth waveform, and the SpO2 Limits screen. The Alaris PC unit will produce an audible alarm and
the attached modules will display a Communications Error message with a flashing red light. Refer to the Recall Notice for additional details.
When the Alaris PC unit experiences a communication error, the programmed infusion(s) will continue as programmed. However, no further key
presses on the Alaris PC unit have an effect on the system except for the System On key which allows the user to power down the device. Powering
down of the device results in termination of all infusions. Termination of an infusion could result in serious injury or death.
The Alaris PC unit (model 8015) is part of the Alaris electronic infusion pump. An electronic infusion pump delivers controlled amounts of medications
or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
Either discontinue the use of the EtCO2 or SpO2 module(s) until the correction has been implemented by CareFusion, or weigh the risk/benefit to
patients before continuing to use the Alaris EtCO2 module or Alaris SpO2 module(s). If you experience a communication error on the Alaris PC unit,
contact CareFusion Customer Advocacy at 1-888-812-3266, 24 hours a day, 7 days a week or by email at customerfeedback@carefusion.com.
Animas Corporation 2020 Insulin Infusion Pump: Class I Recall - False Alarm or Warning Sound
(posted 4/5/2013)
Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The
component issue may trigger the pumps to sound a false alarm or warning related to one of the following:
Loss of prime
Occlusion
No Cartridge detected
If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow
the pumps safety instructions and disconnect your infusion set from your body before the rewind, load and prime steps can lead to unintended
delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.
The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this
date, the pump will no linger deliver insulin and will generate a Call Service Alarm.
146/166
4/6/2016
FDASafetyAlerts
The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.
Customers with the device should contact Animas Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to
schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer
Technical Support Center at 866-793-5253.
Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting
(posted 3/18/2013)
Symbios Medical Products, LLC sent its customers an "URGENT MEDICAL DEVICE RECALL" notification letter detailing the reason for recall and products
listed. The reason for the recall is that the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher
rate than intended. This product may cause serious adverse health consequences, including death. These kits were distributed between Sept. 10, 2012
and Feb. 11, 2013. Refer to the Recall Notice for a list of kit part numbers.
The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system using an inflatable elastomeric reservoir to mechanically
provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
Customers are asked to: segregate recalled product, complete verification form, indicate returned products on verification form, obtain a returned
goods authorization (RGA) number, and package the returned products. Refer to the Recall Notice for details.
Medtronic Drug Infusion Pumps: Recall - Intermittent or Permanent Pump Motor Stall
(posted 12/21/2012)
FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the
pumps performance. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. A
cessation of drug infusion may cause serious adverse health consequences, including death.
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps contain and administer prescribed drugs or fluids to a specific site inside the
patients body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine,
Methotrexate and Gablofen.
These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012. Model
numbers can be found in the recall notice.
To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the
SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump. Do not use compounded drugs,
147/166
4/6/2016
FDASafetyAlerts
unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump

Refer to the Medtronic Medical Device Safety Notification, sent November 9, 2012 to healthcare professionals which includes detailed information
about this issue. In addition to the Healthcare Professional Letter, the safety notification provided a white paper documenting the Increased Risk of
Motor Stall and Loss of or Change in Therapy when Unapproved Drug Formulations are used with the SynchroMed Pump and a summary of the drugs
that are approved to be used with the SynchroMed.
Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected
(posted 11/8/2012)
Baxter Healthcare Corp. (Baxter) has initiated a voluntary recall of its Buretrol Solution Sets because the ball-valve feature may not function as
expected. Baxter has determined that the ball-valve component is allowing air to flow past the valve and enter the tubing once the pre-measured
amount of fluids is completely administered to the patient. If the air is not removed, the air present in the tubing may enter the patients vascular
system potentially causing air in the bloodstream (an air embolism). This product may cause serious adverse health consequences, including death.
Baxter Healthcare Corp. Buretrol Solution Sets are non-reusable, disposable devices used for the administration of fluids from a container into the
patients blood vessels (vascular system) through a device that allows frequent access to patients veins (a vascular access device). Products were
manufactured from April 30, 2003 through July 26, 2012 and were distributed from May 1, 2003 through August 16, 2012. For products affected see
Recall Notice.
On September 7, 2012, Baxter Healthcare sent an Urgent Product Recall letter to affected customers informing them of the problem with the ball-valve
feature. Customers were asked to do the following:
STOP using affected Buretrol Solution Sets.
Contact Baxter for instructions on how to return the affected product.
Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection
(posted 10/29/2012)
FDA notified healthcare professionals and provider organizations of the Class 1 recall of the Symbiq pump touchscreen. These devices may not
respond to user selection, may experience a delayed response or may register a different value from the value selected by the user. Failure of the
touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication if the user does
not confirm the programmed values on the pump''s confirmation screen before starting the infusion. All serial numbers for these models are affected
by this recall.
The Symbiq infusion pump is a prescription device used to deliver controlled amounts of medications or other fluids to patients through intravenous,
intra-arterial, epidural, and other acceptable routes of administration. The touchscreen is used to control infusion pump settings for patient therapy.
148/166
4/6/2016
FDASafetyAlerts
On August 29, 2012, an Urgent Device Correction letter [see link in Recall Notice] notifying customers of this recall was mailed by Stericycle, Inc. on
behalf of Hospira. Customers were instructed not to return affected Symbiq infusion pumps. The letter lists steps that users may take to confirm that
infusion settings are correctly entered as well instructions for how to stop an infusion. Health care providers experiencing the described issue should
remove the impacted device from use and contact their institution''s biomedical or clinical engineering department to perform the touchscreen test
described in the Symbiq technical service manual. If the biomedical or clinical engineering department identifies that the device is not working
properly, contact Hospira.
I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected
(posted 8/31/2012)
FDA notified healthcare professionals that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may not lock in the down position when depressed
and/or the orange bolus refill indicator may stay in the lowest most position. When this occurs, the patient may receive continuous infusion at a rate
greater than expected. As a result, this product may cause serious adverse health consequences, including death. See the Recall Notice for a listing of
affected product numbers.
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines (such as local anesthetics or narcotics) to
or around surgical wound sites and/or to nearby nerves for pre-operative, during the procedure/surgery (perioperative), and for post-operative
regional anesthetic and pain management.
On May 8, 2012, the firm sent an IMPORTANT VOLUNTARY RECALL NOTICE to its customers who purchased the ON-Q pump with ONDEMAND bolus
button. Customers should identify all affected products within your inventory and Quarantine the affected products.
Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall - Risk of Fluid Entry into Device Keypads
(posted 8/29/2012)
FDA notified healthcare professional of a Class I recall of Baxter Healthcare Automix Automated Nutrition Compounder Systems, due to incorrect key
press responses, caused by fluid entry into device keypads, and intermittent electrical failures. Fluids, such as water, cleaning solutions, and nutrition
source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an
Automix operator's key press. The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not
programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN)
Solution. Causes for the intermittent electrical failures have not been determined.
The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect
solutions, and/or solution incompatibilities). For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in
dosing in highly vulnerable patients could lead to serious injury and/or death.
149/166
4/6/2016
FDASafetyAlerts
Baxter Healthcare Corp. Automix Compounder Systems are automated nutrition compounders that use weight-based (gravimetric) measuring, often
controlled by software, to provide compounding of total parenteral nutrition (TPN) solutions to a patient.
Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible.
CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction To Stop Infusion
(posted 8/22/2012)
FDA notified healthcare professionals of a Class I Recall of the CareFusion 303, Alaris Pump Module, Model 8100, due to a potential for the pump
module door keypad overlay to become loose, peel away, or separate from the door assembly. This could cause a potential for fluid ingress which
could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.
The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or
intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The
pump module is used for adults, children, and newborns.
Starting on July 20, 2102, each affected customer and distributor received an URGENT: Medical Device Recall Notification letter, FAQs, Summary of
Affected Units and Response Card by overnight courier service. Customers were asked to visually examine the pump module keypad overlay for
obvious signs of overlay separation. (See photo of an example of a separating keypad overlay in link below by locating CareFusions URGENT: Medical
Device Recall Notification letter. The problem may look different on different pump modules). See a listing of affected serial numbers in the FDA Recall
Notice.
Carefusion informed customers that they will contact their facility by phone within 60 days of receiving the letter to schedule a visit to replace the door
assembly on their affected pump module.
B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch
(posted 8/1/2012)
FDA Notified healthcare professionals of a Class I Recall of the B. Braun Infusomat Space Infusion System, due to the potential for breakage of the anti
free flow clip catch located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the
pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow,
especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.
Affected pumps were distributed from November 6, 2008, to December 29, 2011. See the Recall Notice for a list of affected model numbers.
The Infusomat is an infusion pump system used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult,
pediatric, and neonatal patients. This device is used in hospitals.
150/166
4/6/2016
FDASafetyAlerts
B. Braun is contacting customers to make arrangements to have the metal clip catch added to all pumps, as well as modifying door jambs on certain
models:
All Infusomats on the market, which includes pumps with software versions G03, G02, or older, are being upgraded with a metal clip catch. This new
material strengthens the clip catch and eliminates the potential for breakage of the current clip catch which is made of plastic.
The door jamb on pumps with G03 software will be removed from the pump. The original intent of the door jamb was to minimize potential for
breakage. However, it does not eliminate breakage when high forces are applied.
Inclusion of pumps with software versions G02 or earlier. These customers were reminded about the importance of following the instructions for use
to avoid potential IV set misloading. Customers were provided with information about the potential risks that may occur when instructions for use are
not followed and the IV set is misloaded.
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion
(posted 6/15/2012)
Expanded Class I Recall-Serial numbers range from 700000 through 794213. All pumps serviced by SIGMA after September 21, 2010, or remediated
as part of the initial recall notification, and all pumps manufactured after November 1, 2010, are not affected by this expanded recall. SIGMA expanded
their recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the exception as noted above.
These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump
does not issue an alarm when this occurs. These conditions could result in serious injury or death.
MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of Fluid
(posted 6/1/2012)
There is a potential for a reverse pump segment in the administration set. This malfunction could reverse the flow of fluid or medicines backwards
from what was intended. This may cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy. Use of the
affected administration sets may cause serious adverse health consequences, including death.
See the Firm Press Release for a listing of affected product codes and lot numbers.
Curlin Infusion Administration Sets are used to deliver a variety of medicines and other fluids. Curlin Infusion Administration Sets were distributed in
the U.S. between from December 2011 and May 2012.
Patients in a home environment: Contact your home healthcare provider or clinician for proper handling and the replacement process of your affected
administration set(s).
151/166
4/6/2016
FDASafetyAlerts
Healthcare facilities/Pharmacies: Contact your distributor for proper handling and the replacement process of the affected administration sets.
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing Errors
(posted 5/25/2012)
A number of errors have been reported by Abacus software users as a result of ordering salt based parenteral nutrition ingredients on an ion based
ordering template. Abacus TPN Calculation Software is designed and intended to allow the ordering of electrolytes in only one of two ways: as a salt
(such as calcium gluconate 10%) or as an elemental ion (such as calcium). However, if a dosage is entered into the system based on one method, when
the template is configured for the other method, a dosing error can occur.
The problem associated with mix-ups related to salt-based or ion-based ordering of electrolytes is not exclusive to calcium gluconate.
Affected catalogue numbers include:
8300-0045: Abacus Calculator Only (Abacus CE)
8300-0046: Abacus Single Work Station (Abacus SE)
8300-0047: Abacus Multi-Work Station (Abacus ME)
The Abacus TPN Calculating Software is an FDA Class I Laboratory Information Management System (LIMS) Windows-based program used in ordering
total parenteral nutrition. This is a classification of the recall initiated in 2009. As of this posting, over 90% of Abacus users have made corrective
actions.
The Abacus TPN Calculation Software was manufactured and distributed from August 7, 2006 through April 15, 2009.
On January 23, 2009, Baxa Corporation sent its customers a Safety Alert letter. Customers were instructed to ensure that users create either a saltbased template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were also
instructed to establish ingredient warning limits and to have pharmacists sign off if a warning limit is exceeded. In 2009 and 2010, Baxa issued
updates that added limit warnings to the Abacus software.
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall
(posted 9/12/2011)
Medtronic and FDA notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Medtronics analysis of the problem
indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of
underlying symptoms and/or therapy withdrawal symptoms.
152/166
4/6/2016
FDASafetyAlerts
The recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.
The SynchroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion system designed to contain and administer prescribed
drugs to a specific site. This infusion pump is indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe
chronic pain and severe spasticity, respectively. It is also indicated for delivery of floxuridine and methotrexate for the treatment of primary or
metastatic cancer.
Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they
experience a return of symptoms or hear a device alarm.
Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD
(posted 4/8/2011)
April 8, 2011 - EAST AURORA, NY - Moog Inc. (NYSE: MOG.A1) (NYSE: MOG.B2) announced today that the Food and Drug Administration (FDA) has
classified the voluntary correction of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD as a Class I recall. The affected models
were manufactured and updated from May 2007 to February 2011. The decision to conduct the device recall is due to a software anomaly which leads
to software Error Code 45 (EC45), resulting in a shutdown of the pump. This failure may result in a delay or interruption of therapy, which could result
in serious injury and/or death. To date there have been no adverse patient events reported to the Company.
On February 28, 2011, Moog Medical notified all affected customers by Certified Mail and is preparing to take corrective action on the affected
products. In the meantime, Moog Medical is providing the following guidance to its customers.
Moog Medical customers who have affected pumps experiencing an Error Code 45 should remove the pumps from service and return the device to
Moog.
If you have a pump that exhibits the software error, please contact Moog Medical customer service at 1-800-970-2337, Monday through Friday 7:00
am to 5:00 pm Mountain Standard Time to arrange for the return of all recalled products.
"Moog Medical is committed to the highest level of quality in our products," said Martin Berardi, President of Moog Medical Devices Group. "Our goal is
to maximize patient safety and minimize the impact of this field action on our customers." In the first quarter of this year, the Company took a reserve
of $1 million to cover the cost of this recall.
Roche Insulin Delivery Systems announces recall of ACCU-CHEK FlexLink Plus infusion sets
(posted 2/21/2011)
Roche Insulin Delivery Systems announced today that it is notifying its customers and healthcare professionals about the recall of the ACCU-CHEK
FlexLink Plus infusion set, because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the ACCU-CHEK FlexLink
153/166
4/6/2016
FDASafetyAlerts
Plus infusion set. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels.
The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness,
headache, fruity acetone breath and abdominal pain. If untreated hyperglycemia could lead to Diabetic Ketoacidosis (DKA), serious illnesses and in
severe cases death. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an
acceptable range as defined by the patients healthcare team and to follow the medical advice given by the their healthcare team or contact their
physician.
Roche Insulin Delivery Systems advises all customers to discontinue use of ACCU-CHEK FlexLink Plus infusion set and to contact their physicians or
caregivers to determine if any changes to their therapy are needed and the local ACCU-CHEK Customer Care 1-800-688-4578 to receive support on
obtaining alternative infusion sets, such as the ACCU-CHEK Tender or ACCU-CHEK Rapid-D infusion set. Until this issue is fixed, the ACCU-CHEK
FlexLink Plus infusion sets will not be available.
Roche Insulin Delivery Systems emphasizes that the above mentioned action only applies to the ACCU-CHEK FlexLink Plus infusion set that was
launched in November 2010. The use of the previous version ACCU -CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not
affected and insulin pump therapy can be continued as directed with these products or other alternatives.
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall
(posted 2/16/2011)
Pocket fills (the unintended injection of drugs or fluids into the patients subcutaneous tissue at the pump pocket site instead of the pump) may result
in patient harm, serious injury, and/or death due to drug overdose or underdose.
Products Affected:
SynchroMed II (Model No: 8637)
SynchroMed EL (Model No: 8626 and 8627)
Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566)
The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the constant
delivery of drugs or fluids into a patients body. The Medtronic refill kit is used in refilling Medtronic implantable infusion pumps, with the exception
of Medtronic MiniMed Infusion Pumps.
Medtronic reminded healthcare professionals to check needle placement within the pump septum during the drug refill procedure. According to
Medtronic, it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir. At every refill,
patients and caregivers should be reminded about the signs and symptoms of drug overdose, underdose, and withdrawal.
B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag
154/166
4/6/2016
FDASafetyAlerts
(posted 11/30/2010)
When the addEASE binary connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a
small amount of visible particles in the solution. The particles can potentially enter a patients body and lead to serious adverse health consequences,
such as pulmonary embolism, stroke, or heart attack. These issues could result in serious injury or death.
The addEASE is used to transfer fluid between a partial additive bag (PAB) and a drug vial.
On June 28, 2010 B Braun sent an Urgent Medical Device Recall letter to its customers informing them of the recall and advising them to immediately
stop using or distributing addEASE connectors.
Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use.
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall
(posted 11/12/2010)
FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing
inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this
occurs. These conditions could result in serious injury or death. The recalled pump is intended for the delivery of fluids, solutions, drugs, agents,
nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of
administration. The recall was initiated September 15, 2010 and includes serial numbers from 706497 to 724065. Sigma has instructed healthcare
facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the
recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow,
ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.
Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem
(posted 11/8/2010)
WalkMed Infusion LLC notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500
and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. If the pump door is not closed and latched per the
instructions for use located on the side of the pump and in the operator manual, the pump door open alarm may not alert the user to this condition. It
is then possible for the pump mechanism not to be engaged and a gravity feed flow condition to exist if the pump operator has not checked tube set
for flow prior to starting the pump. This could result in over infusion of medication.
WalkMed Infusion has notified its distributors and customers by phone and e-mail and has begun the upgrade of all recalled products.
Consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer.
155/166
4/6/2016
FDASafetyAlerts
CareFusion Corporation Alaris PC Units (Model 8015): Recall

(posted 10/15/2010)
Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of
therapy and inability to make programming changes to current infusions.
If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this
error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or
interruption in therapy. This could lead to serious injury and/or death. These devices were manufactured from December 20, 2008 through September
8, 2009 and distributed from December 20, 2008 through June 28, 2010.
Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural,
and other acceptable routes of administration.
If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective
action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall
(posted 9/10/2010)
Potential for the device to fail to detect air in line at the end of an infusion. Failure to detect air in line may result in the delivery of air to the patient,
resulting in serious injury or death.
The Symbiq Infusion System is an infusion pump intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and
blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter,
Hospira states the user does not have to remove or stop using the Symbiq infusion pump, and provided recommended mitigation actions.
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens
(posted 8/26/2010)
Reusable fingerstick (blood lancing) devices and point of care (POC) blood testing devices (e.g., blood glucose meters, PT/INR anticoagulation meters,
cholesterol testing devices)
FDA and CDC have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B
virus), resulting from the shared use of fingerstick and point-of-care [POC] blood testing devices.
156/166
4/6/2016
FDASafetyAlerts
Fingerstick and POC blood testing devices used on more than one patient may not be safe for several reasons. Improper use or device malfunction can
lead to the use of the contaminated lancet blade on more than one patient. It is difficult for healthcare staff to ensure that all blood has been removed
from POC blood testing devices and the reusable portions of the fingerstick device. If POC blood testing devices are used on multiple patients and are
not cleaned and disinfected correctly and thoroughly between each patient, contaminated blood left on them could result in bloodborne pathogen
transmission among patients.
Fingerstick devices are instruments equipped with a lancet. These devices are used for making skin punctures to obtain small blood specimens which
are tested for blood glucose, hemoglobin, and other blood components. Some fingerstick devices are packaged with POC blood testing devices, such
as blood glucose meters and PT/INR anticoagulation meters, while other fingerstick devices and lancet blades are sold separately.
Fingerstick devices should never be used for more than one person. Whenever possible, POC blood testing devices, such as blood glucose meters and
PT/INR anticoagulation meters, should be used only on one patient and not shared. If dedicating POC blood testing devices to a single patient is not
possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.
INOMAX DS Drug-Delivery System: Class I Recall
(posted 8/23/2010)
Ikaria, Inc. notified healthcare professionals of a Class I Recall of the INOMAX (nitric oxide) Drug-Delivery System. There is a potential for failure of a
pressure switch which may have an impact on the administration of INOMAX for inhalation to patients. Risks to the patient may include interruption of
drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system. An interruption or delay in the administration of
INOMAX therapy may cause:
Worsening of low blood oxygen level (hypoxemia)
Low blood pressure (hypotension) and/or
Increase in blood pressure in the pulmonary arteries (pulmonary hypertension)
Death
INOMAX is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and nearterm (greater than 34 weeks gestation) neonates with hypoxic respiratory failure.
If a leak is suspected, clinicians should: 1) not interrupt the delivery of INOMAX; 2) verify an adequate amount of INOMAX remains in the cylinder; 3)
switch to the manual back-up system using the INOblender by connecting the INOMAX Inlet Hose of the INOblender directly to the INOMAX regulator,
and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation, and; 4) contact Ikaria Customer
Care at 1-877-KNOW-INO (1-877-566-9466) for assistance. Although the risk of INOMAX exposure to pregnant women is unknown, it is advised that
healthcare professionals who may be pregnant avoid the immediate area in which a leak is suspected.
Baxter Colleague Infusion Pumps: FDA Ordering Recall
157/166
4/6/2016
FDASafetyAlerts
(posted 5/4/2010)
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps
(Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes
there may be as many as 200,000 of those pumps currently in use. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps,
reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of
Baxters Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.
Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall
(posted 3/18/2010)
FDA notified healthcare professionals of the Class 1 recall of certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products,
including kits and trays, sold by other companies in which the Q-Syte Luer Access device is a component.
This device is used with other infusion therapy products to administer therapies, such as chemotherapy, blood and fluids into the intravenous system.
The affected BD products were distributed from August 1, 2008 through February 1, 2010.
These lots of the BD Q-Syte Luer Access Split Septum devices are defective, which may result in air bubbles leaking into the infusion system and into
the patients bloodstream, resulting in an air embolism. In addition, these defective devices may result in leakage of therapy being infused and result
in incomplete inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in
serious injuries or death.
For specific information on the affected products, see the list of recalled devices in the appendix of the Initial Communication.
OneTouch SureStep Test Strips (LifeScan): Recall
(posted 2/26/2010)
LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to
measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose
level is higher than 400 mg/dL.
If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood
glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.
The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the
outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep
Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.
158/166
4/6/2016
FDASafetyAlerts
It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch
SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not
available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they
should contact their healthcare professional for further instructions because their glucose may be significantly higher.
Medtronic Intrathecal Catheters and Revision Kits
(posted 9/24/2009)
FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC
when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter
connector and the IsoMed pump. This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be
connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.
SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic
has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump. In all ten reports, medical intervention was
required to correct the condition. Medtronic has provided recommendations in their Medical Device Correction Letter (see link in FDA Recall Notice).
Accusure Insulin Syringes: Nationwide recall
(posted 8/21/2009)
Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin
Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the
syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have
any recalled Accusure Insulin Syringes (31 G Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and
contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each
individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide
(including Puerto Rico).
Hospira, Inc. Device Recall - Defective AC Power Cords
(posted 8/17/2009)
Hospira and FDA notified healthcare professionals and patients of a nationwide recall of devices that have defective AC power cords in response to
customer reports of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power
cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and
therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy,
these failures may lead to potential serious injury or death. For a list of the recalled devices please refer to the firm press release.
Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and
159/166
4/6/2016
FDASafetyAlerts
contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time)
for instructions on receiving replacement parts or devices.
Alaris System (Cardinal Health)
(posted 8/5/2009)
FDA notified healthcare professionals of the Class 1 recall of various modules of Cardinal Healths Alaris System, electronic infusion pumps that deliver
controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, and other routes of administration. The
firm initiated the recall after identifying five problems that affected the Alaris System, including failure of the occlusion warning message, syringe
volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. It was determined that the five failures may result in
patients experiencing under- or over-infusion which may result in serious injury or death.The device is intended for use with adult and pediatric
patients in hospitals including critical care units, emergency rooms, outpatient surgical centers, hospices, and nursing homes.
Carefusion Issues Update Regarding Previously Disclosed June 12, 2009 Recall of the Alaris
(posted 7/30/2009)
CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following
update regarding its previously disclosed recall of the Alaris System:
On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris System addressing potential risks
identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume
Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device's pumping mechanism. This recall also updates the
labeling for the Inter Unit Interface (IUI) connectors on the Alaris System. The potential risks may lead to improper infusion therapy, which could
cause serious adverse health consequences or death.
Serial numbers of affected devices, as well as CareFusion's short term instructions to customers, and the firm's strategy to fix the affected devices can
be found at: www.cardinalhealth.com/alaris/medical-device-recall/.
Following the FDA's 510(k) clearance of the firm's software correction in July 2009, CareFusion is now implementing corrections for units in the field.
In addition, CareFusion today began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009,
Medical Device Recall Notification. The update contains an additional required action to mitigate potential risk before completion of the field corrective
action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module. The additional step
involves removing the patient-controlled dose request handset from the patient prior to reprogramming the infusion pump.
"Implementation of the corrective action plan is an important area of focus for CareFusion and our customers, to ensure our medical devices in the
field are operating as safely and effectively as possible," said Dwight Winstead, chief operating officer of CareFusion. "We continue to work closely with
160/166
4/6/2016
FDASafetyAlerts
the FDA under our new quality system with the goal of manufacturing and supporting products that are among the safest in the industry."
The company recorded an $18 million reserve in its 2009 fiscal third quarter for all actions related to the corrective action plan and continues to
believe the amount to be sufficient to fulfill its remediation obligations.
Instructions to customers
Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the
recall can be found at www.cardinalhealth.com/alaris/medical-device-recall/.
CareFusion will work with customers to minimize disruption while correcting units at their facilities.
In the interim, customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers
using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates.
CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company's web site and set up a dedicated call
center for customer support. The FDA has also been apprised of this action.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by
phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or at
www.fda.gov/medwatch.
About CareFusion Corporation
CareFusion Corporation, a wholly owned subsidiary of Cardinal Health (NYSE:CAH), is expected to become a public company with the planned spinoff
of the clinical and medical products businesses of Cardinal Health. The global company serves the health care industry with products and services that
help hospitals measurably improve the safety and quality of healthcare. CareFusion develops market-leading technologies including Alaris IV pumps,
Pyxis automated dispensing and patient identification systems, AVEA and Pulmonetic Systems ventilation and respiratory products, ChloraPrep for
infection prevention and MedMined services for infection surveillance, neurological monitoring and diagnostic products, V. Mueller surgical
instruments and an extensive line of products that support interventional medicine.
CareFusion employs more than 15,000 people across its global operations. The company has been authorized to have its shares of common stock
listed on the New York Stock Exchange under the ticker symbol "CFN." More information may be found at carefusion.com.
Mallinckrodt Sodium Chromate Cr-51 Injection
(posted 7/10/2009)
161/166
4/6/2016
FDASafetyAlerts
Covidien and FDA announced the recall of one lot [#370-9004] of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-market
testing in which the product was found to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical agent used in a diagnostic test to
determine the presence of a disease known as Polycythemia rubra vera. Using subpotent product could lead to an incorrect test result. A misdiagnosis
or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform
healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product. Customers who have
product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including
returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT).
Disetronic Medical Systems Inc. announces a recall the ACCU-CHEK Spirit insulin pump
(posted 4/30/2009)
Disetronic Medical Systems Inc. announced today that it is notifying its customers, distributors and healthcare professionals about a potential defect in
the up and/or down buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of
the up and/or down buttons. The pumps up and down buttons are used for changing the program in the menu or to administer additional
insulin through a bolus delivery. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure
occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. This
defect was discovered through the companys normal quality control monitoring process.
The notifications provide specific actions and details that customers, distributors and healthcare professionals need to take. The pumps in question
have serial numbers in the range from SN02119552 through SN10006093 (US market).
Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter recalled
(posted 3/12/2009)
FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE
2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified
software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter
to all of its customers, which included advice and instructions to institutions using the infusion pumps.
Nationwide Recall of ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
(posted 11/5/2008)
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with
permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended
dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under
the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes
471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with
this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of
162/166
4/6/2016
FDASafetyAlerts
the 100 count syringe carton, or on the white paper backing of each individual syringe peel-pack.
Medtronic INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
(posted 10/2/2008)
Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision
kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the
intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter
port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and
disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.
Recall Issued For Baxa Corporation Exacta-Mix 2400 Operating Software
(posted 9/27/2007)
Baxa Corporation and FDA informed healthcare professionals of a class I recall of Exacta-Mix 2400 Operating Software Version 1.07, Model No. 83000073, Pharmacy Compound System. The device is a compounding system that can be used in pharmacies to add and mix various ingredients into one
intravenous (IV) solution.
The device is being recalled because a software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be
life-threatening, particularly in newborns.
Medical Equipment That Uses or Displays Time
(posted 3/2/2007)
FDA notified healthcare professionals and consumers of the possibility that some medical devices/equipment, hospital networks and associated
information technology systems may generate adverse events because of the upcoming change in the start and end dates for Daylight Savings Time
(DST), and suggested actions to prevent such occurrences. Medical equipment that uses, creates or records time information about a patient's
diagnosis or treatment and has not been updated by the manufacturer, may not work properly when the new DST starts three weeks earlier and ends
one week later this year.
Additionally, if a medical device or medical device network are adversely affected by the new DST date changes, a patient's treatment or diagnostic
result could be:
- incorrectly prescribed
- provided at the wrong time
- missed
- given more than once
- given for longer or shorter durations than intended
163/166
4/6/2016
FDASafetyAlerts
- incorrectly recorded
Alaris SE Infusion Pumps recalled due to risk of overinfusion
(posted 8/29/2006)
FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may
cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic
devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the
pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and
7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to
minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the
company's instructions. To learn more about the problem with "key bounce", go to
http://www.ismp.org/Newsletters/acutecare/articles/20060112.asp
Baxter Healthcare's Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump
(posted 7/7/2006)
FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion
Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's
current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine
service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of
customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms
and failure to alarm.
Baxter Healthcare Corporation COLLEAGUE Volumetric Infusion Pumps
(posted 4/28/2006)
The FDA is recommending that all healthcare providers take important safety steps when using the COLLEAGUE Volumetric Infusion Pump
manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures,
false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps.
In addition to the recommendations made by Baxter Healthcare Corporation when using the COLLEAGUE Volumetric Infusion Pump, FDA is strongly
recommending the following measures:
- Do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may
be life threatening, if possible.
- Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available).
164/166
4/6/2016
FDASafetyAlerts
- Monitor patients and check the pumps frequently.

- Report any problems as soon as possible to Baxter and FDA.
- Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on COLLEAGUE Pumps.
Advisory for Users of Diastat AcuDial Delivery Systems
(posted 4/3/2006)
The Food and Drug Administration is advising patients with epilepsy and their care givers of a potential hazard caused by cracks in the applicator tips
of Diastat AcuDial (diazepam rectal gel) delivery systems. These cracks can result in the leakage of gel during its application, which results in the
patient not getting enough of the medicine to control seizures. Caregivers for these patients are advised to call their local emergency response center
or 911 for help in any seizure emergency.
Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if
inadequately treated, can progress to a life-threatening condition in which seizures are continuous. The drug is typically administered by family
members or caregivers at home.
Class 1 recall of Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pump
(posted 2/2/2006)
Baxter Healthcare Corp. and FDA notified healthcare professionals of a Class 1 recall of all models of COLLEAGUE Volumetric Infusion Pumps, used to
give controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural or other direct line into the
bloodstream. Reasons for the recall include one or more of the following conditions: battery undercharging, false alarms/shutdown, gearbox wear,
under-infusion, and/or non-detection of upstream occlusion. Any of these failures may delay or interrupt therapy, which could result in a lifethreatening situation for patients, depending on the type of therapy being administered.
Baxter Healthcare Colleague Volumetric Infusion Pump
(posted 7/21/2005)
Baxter Healthcare Corporation and FDA notified healthcare professionals of a Class I recall of all models of its Colleague Volumetric Infusion Pumps
because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three
reports of death associated with this shut-down problem.
165/166
4/6/2016
FDASafetyAlerts
Home | Contact Us |Employment |Legal Notices| Privacy Policy | Help Support ISMP
ISMP Canada|
Med-ERRS |
Medication Safety Officers Society |
For consumers
ISMP Spain |
ISMP Brasil | International Group | Pennsylvania Patient Safety Authority
200 Lakeside Drive, Suite 200, Horsham, PA 19044 , Phone: (215) 947-7797, Fax: (215) 914-1492
2016 Institute for Safe Medication Practices. All rights reserved
166/166

FDA Safety Alerts

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

FDA Safety Alerts

Uploaded by

Copyright:

Available Formats

4/6/2016

Home Support ISMP

FDA SAFETY ALERTS

FOR DRUGS AND MEDICATION-RELATED MEDICAL DEVICES

THERAPEUTIC BIOLOGICAL PRODUCTS

communicated when the FDA review is complete.

Mucinex Fast-MAX Products: Recall - Incorrect Labeling

See the press release for a listing of affected products.

Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-St

may develop persistent symptoms and disability over time.

Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance

patient risk factors.

NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk

2012 and March 19, 2013.

Refer to the Drug Safety Communication for more details.

No injuries have been reported to date.

significant and sometimes fatal bleeds. In a

renal function in patients who are receiving Reclast.

Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency

interfering gas shadows, and in diabetes insipidus.

Nationwide Recall of Two Lots of Endocet

Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion

Topamax (topiramate): Recall - Musty Odor

Product Batch Number Expiration Date Product Identification

intended to reduce the risk of medication errors.

Propoxyphene: Withdrawal - Risk of Cardiac Toxicity

Heparin Sodium (B. Braun): Recall - Trace Contaminant

Tylenol 8 Hour Caplets 50 Count: Recall

Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

warnings of an antihistamine in the product that could cause drowsiness.

Libimax - Recall of dietary supplement due to undeclared drug tadalafil

Raptiva (efalizumab) - Withdrawn from market

Watson Announces Voluntary Recall of Propafenone HCL Tablets

Myfortic (mycophenolic acid) Medication Guide released

Epoetin alfa - Early Communication about an Ongoing Safety Review

Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01295.html

2. acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or

3. dextromethorphan HBr, and pseudoephedrine HCl.

Disconnect the affected product from the network.

unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump

CareFusion Corporation Alaris PC Units (Model 8015): Recall

- Monitor patients and check the pumps frequently.

Medication Safety Officers Society |

ISMP Brasil | International Group | Pennsylvania Patient Safety Authority

You might also like