Safety Alerts & Recalls

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Generic Manufacturer Recalls Several Drug Products
Actavis Totowa LLC, a generic drug manufacturer, has voluntarily recalled all drug products manufactured at its Little Falls, New Jersey facility. An FDA inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. This recall includes all Amantadine 100 mg capsules manufactured by Actavis Totowa, LLC. For more information, please visit: http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112477.htm or http://www.actavis.us/RecallFAQ
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Combination use can lead to rare condition of muscle damage
The FDA is notifying the public of an increased risk of muscle breakdown (rhabdomyolysis) when the cholesterol-lowering medication simvastatin (marketed as Zocor and generics), Ezetimibe/Simvastatin (marketed as Vytorin), or Niacin Extended-Release /Simvastatin (marketed as Simcor), is used with amiodarone (Cordarone, Pacerone), a drug used for abnormal heart rhythms. Rhabdomyolysis is a rare condition which can lead to kidney failure if not detected early. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118869.htm
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Date Published Title Drug Source
2008-08-04 Generic Manufacturer Recalls Several Drug Products Amantadine Manufacturer
2008-08-08 Combination use can lead to rare condition of muscle damage Amiodarone FDA
2009-01-28 Recall on All ETHEX Brand Amlodipine Tablets Amlodipine Manufacturer
2008-08-13 Angioedema and ACE inhibitors Amlodipine Besylate with Benazepril MediGuard CRT
2009-10-18 Three Lots of Lac-Hydrin Recalled Ammonium Lactate FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Amoxicillin FDA
2010-07-20 Amoxicillin for Oral Suspension: Recall by Teva Pharmaceuticals Amoxicillin FDA
2010-08-11 Teva Recalls Select Lots of Amoxicillin for Oral Suspension, 400 mg/5 mL Amoxicillin FDA
2011-05-11 Multi-Mex Distributor Inc. Announces Recall of Dietary Supplements Amoxicillin FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Amoxicillin Sodium with Clavulanate Potassium FDA
2010-04-12 Amoxicillin and Clavulanate Potassium for Oral Suspension: Recall by Ranbaxy Amoxicillin Sodium with Clavulanate Potassium FDA
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Amphetamine Salts FDA
2009-08-14 Recall on Single Lot of Barr Laboratories Brand Dextroamphetamine/Amphetamine 20mg Tablets Amphetamine Salts FDA
2012-05-30 FDA Warns Consumers About Counterfeit Version of Teva’s Adderall Amphetamine Salts FDA
2011-06-01 Pentrexyl Forte Natural Recalled Due to Misleading Packaging Ampicillin FDA
2009-02-04 Recall on ETHEX Brand Iron Supplements Manufacturer
2011-03-10 New Study: Mothers Taking Opioid Pain Medicines May Place Infants At Increased Risk for Birth Defects MediGuard CRT
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Angeliq MediGuard CRT
2012-08-29 Genzyme Recalls Select Lots of Thymoglobulin Manufacturer
2007-09-13 FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol Manufacturer
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