Safety Alerts & Recalls

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Latest Alerts

Pfizer Recalls Some Lots of Antidepressant Effexor
Pfizer Inc. has issued a recall of three lots of its antidepressant, Effexor XR (venlafaxine), after a pharmacist reported that one bottle of the medication contained a capsule of another product, Tikosyn (dofetilide) 0.25mg, in addition to the Effexor XR capsules. While there is a very low probability that other bottles contain Tikosyn capsules, two lots of Pfizer’s Effexor XR 150 mg antidepressant (lots V1301452 and V130140) and one lot of its generic form, Venlafaxine Extended Release 150 mg (Lot number V130014) are being recalled as a precaution. Effexor XR is an antidepressant indicated for the treatment of major depressive disorder, general anxiety disorder, social anxiety disorder, and panic disorder. Tikosyn is an antiarrhythmic drug used to treat irregular heartbeats (such as atrial fibrillation (AF) and atrial flutter (AFL)). Accidental use of Tikosyn could result in serious adverse health consequences that could be fatal. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm388329.htm and http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm To view pictures of the two different capsules, please visit: http://www.fda.gov/Safety/Recalls/ucm388330.htm
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Manufacturer Recalls Specific Lots of L-Citrulline After Reports of Adverse Events
The Food and Drug Administration (FDA) has received adverse event reports associated with L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, which are rare genetic disorders primarily diagnosed in children. Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that these lots did not contain any L-citrulline. Using a product that does not contain L-citrulline can lead to seriously and potentially life threatening ammonia levels in patients with certain urea cycle defects The recalled lot number of L-citrulline are 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D. The FDA has tested samples from the recalled lots and has found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness (acute vestibular vertigo). No L-citrulline was found in the samples that the FDA tested. L-citrulline is sold to pharmacies, hospitals, and clinics in containers filled with powdered L-citrulline. It may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder. These compounded L-citrulline products used by patients may be labeled with only their pharmacy’s information and may not be labeled with information about the source of the L-citrulline or its original lot number. Pharmacies have this information in their records. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm385964.htm and http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385978.htm
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Date Published Title Drug Source
2014-03-07 Pfizer Recalls Some Lots of Antidepressant Effexor Venlafaxine Manufacturer
2014-02-20 Manufacturer Recalls Specific Lots of L-Citrulline After Reports of Adverse Events Citrulline FDA
2014-02-20 Ben Venue Laboratories, Inc. Recalls Single Lot of Acetylcysteine Solution 10%, 30 mL Vial Acetylcysteine FDA
2014-02-12 FDA Reviewing Saxagliptin (Onglyza or Kombiglyze XR) Trial Data for Possible Heart Failure Risk Saxagliptin FDA
2014-02-04 NewMarket Health Products, LLC Recalls Single Lots of NorthStar Arthritis Relief Cream Menthol FDA
2014-02-04 Greenstone LLC Recalls Single Lot of Nifedipine, Extended-Release 90 mg Tablets Nifedipine FDA
2014-02-03 FDA to Evaluate Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products Methyltestosterone FDA
2014-01-17 Some Over-the-Counter Wart Removers Are Flammable Dimethyl Ether and Propane FDA
2014-01-15 Tandem Diabetes Care Issues Recall for Insulin Cartridges Used with t:slim Insulin Pump Insulin FDA
2014-01-15 Merck Recalls All Lots of Liptruzet Atorvastatin and Ezetimibe Manufacturer
2014-01-15 New FDA Recommendations Aimed at Cutting Risks from Acetaminophen FDA
2014-01-10 Nipro Recalls TRUEtrack and TRUEbalance Glucose Meters Insulin Aspart FDA
2014-01-08 FDA Warns of Possible Harm From Exceeding Dose of Over-the-Counter Enemas and Oral Solutions Used to Treat Constipation FDA
2014-01-02 FDA Requires New Safety Measures for Iclusig (Ponatinib) Before It Can Return to Market Ponatinib FDA
2013-12-17 FDA Warns of Rare Risk of Priapism Associated with Methylphenidate Products Dexmethylphenidate FDA
2013-12-03 FDA Warns of Risk of Serious Skin Reactions with Onfi (Clobazam) Clobazam FDA
2013-11-27 FDA Removes Some Prescribing and Dispensing Restrictions For Rosiglitazone-Containing Medicines, Including Avandia, Avandamet, and Avandaryl Glimepiride and Rosiglitazone FDA
2013-11-21 FDA Warns About Risks of Lexiscan (Regadenoson) and Adenoscan (Adenosine) Adenosine FDA
2013-11-04 Perrigo Recalls Several Store Brands of Acetaminophen Infant Suspension Liquid Due to Potential Defect with the Oral Syringe Included in Packaging Acetaminophen FDA
2013-11-01 FDA Adds Black Box Warning and Updates Warnings for Anti-Seizure Medicine Potiga (Ezogabine) Ezogabine FDA