Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

Corepharma LLC Recalls Several Lots of Ropinirole Hydrochloride Tablets, 0.25, 0.5, 1, 2 mg
Corepharma LLC has recalled several lots of Ropinirole Hydrochloride Tablets, 0.25, 0.5, 1, 2 mg. This recall was issued because samples from these lots did not pass the manufacturer's routine tests for impurities and by-products from chemical breakdown over time. Ropinirole is used in the treatment of restless leg syndrome or Parkinson’s disease. Ropinirole is also sold under the brand name Requip. No other lots, strengths, or brands of Ropinirole were involved in this recall. To view the FDA notice about this recall and a list of lot numbers involved, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm281022.htm
Learn More

FDA Evaluating Reports of Bleeding in Patients Taking Pradaxa
The U.S. Food and Drug Administration is evaluating 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 significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs. The FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected. The FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available. Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of blood clots. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm
Learn More

Date Published Title Drug Source
2011-12-06 Corepharma LLC Recalls Several Lots of Ropinirole Hydrochloride Tablets, 0.25, 0.5, 1, 2 mg Ropinirole FDA
2011-12-08 FDA Evaluating Reports of Bleeding in Patients Taking Pradaxa Dabigatran FDA
2011-12-14 Novartis Looking into Death of MS Patient Who Took Gilenya Fingolimod MediGuard CRT
2011-12-14 FDA Warns HCG Diet Products Are Illegal FDA
2011-12-15 FDA Update: Safety Information for Antidepressant Use During Pregnancy Paroxetine FDA
2011-12-15 FDA Revises Dose Limitation for Zocor (simvastatin) When Taken with Amiodarone Simvastatin FDA
2011-12-19 FDA Completes Safety Review of Multaq and Updates Prescribing Information Dronedarone FDA
2011-12-20 FDA Announces Safety Review of a Reported Death After the First Dose of Gilenya Fingolimod FDA
2011-12-22 Nycomed Recalls Select Lots of Omnaris (ciclesonide) Nasal Spray, 50mcg Ciclesonide Nasal FDA
2011-12-22 McNeil Recalls Certain Lots of Motrin Ibuprofen Manufacturer
2011-12-22 Eclectic Institute Recall Specific Dietary Supplements Containing Gotu Kola (Centella Asiatica) And Bladderwrack (Fucus Vesiculosus) Due to Possible Bacteria Contamination FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available Acetaminophen FDA
2011-12-29 FDA Alerts Pharmacists and Health Care Professionals to Potential for Mix-up when Dispensing the Drugs Durezol and Durasal Salicylic Acid FDA
2012-01-02 FDA Approves Risk Management Plan for Entire Class of Transmucosal Immediate-Release Fentanyl (TIRF) Medicines Fentanyl FDA
2012-01-04 Biovail Corp. Recalls Single Lot of Wellbutrin XL 150 mg Bupropion FDA
2012-01-04 Mylan Pharmaceuticals Inc. Recalls Single Lot of Verapamil HCI Extended-Release Capsules, 180 mg Verapamil FDA
2012-01-04 Alkem Laboratories Recalls Several Lots of Metformin Hydrochloride, Tablets USP, 850 mg and 1000 mg Metformin FDA
2012-01-04 Teva Pharmaceuticals USA Recalls Single Lot of Hydralazine Hydrochloride Tablets, USP, 25 mg Hydralazine FDA
2012-01-09 Novartis Consumer Health Inc. Issues Voluntary Recall Of Certain Excedrin, Bufferin, and Gas-X Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps FDA