Safety Alerts & Recalls

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Latest Alerts

Withdrawal of Unapproved Oral Colchicine Products
The U.S. Food and Drug Administration (FDA) took action against companies that manufacture and distribute unapproved single-ingredient oral colchicine. It is a priority for the FDA to get unapproved medications, such as older versions of single-ingredient oral colchicine, either updated to conform to FDA's current approval standards or off the market. The companies are expected to stop manufacturing these single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product within 90 days. Currently, Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. To view, the FDA's question and answer webpage, please visit: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm227961.htm For more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227796.htm
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Bristol-Myers Squibb Co. is Recalling 60 Million Tablets of Avalide
On behalf of the Bristol-Myers Squibb and Sanofi-Synthelabo partnership, Bristol-Myers Squibb Co. is recalling 62 lots of Avalide 300 mg/25 mg tablets because of the possibility that one of the active ingredients in Avalide, irbesartan, may dissolve at a slower than optimal rate. Although a full review of post-marketing safety reports has not shown any evidence that the recalled tablets are less effective at lowering blood pressure, the company has issued the recall because they are unable to rule out that possibility. Avalide contains the active ingredients irbesartan and hydrochlorothiazide. The recalled tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide. The recalled lot numbers were manufactured before November 2009. For more information, please visit: http://www.reuters.com/article/idUSTRE68S3KF20100929
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Date Published Title Drug Source
2010-10-01 Withdrawal of Unapproved Oral Colchicine Products Colchicine FDA
2010-10-04 Bristol-Myers Squibb Co. is Recalling 60 Million Tablets of Avalide Hydrochlorothiazide with Irbesartan Manufacturer
2010-10-08 Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia Sibutramine FDA
2010-10-10 Pfizer Recalls Several Bottles of Lipitor Because of Strange Smell Atorvastatin Manufacturer
2010-10-13 FDA Updates Prescribing Information to Warn of Possible Fracture Risk With Osteoporosis Drugs Ibandronate Sodium FDA
2010-10-15 FDA Provides Answers to Common Questions About Unapproved Chelation Products FDA
2010-10-19 McNeil Consumer Healthcare Recalls Single Lot of Tylenol 8 Hour Caplets Acetaminophen Manufacturer
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Estrogens Conjugated with Medroxyprogesterone MediGuard CRT
2010-10-21 Hormone Replacement Therapy After Menopause Associated with Higher Risk of Aggressive Form of Breast Cancer Angeliq MediGuard CRT
2010-10-21 New Safety Warnings Added to Gonadotropin-Releasing Hormone (GnRH) Agonists Lupron FDA
2010-10-21 Warnings of Risk of Abnormal Heart Rhythm Added to Prescribing Information for Invirase Saquinavir FDA
2010-10-22 Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/hr Fentanyl Manufacturer
2010-10-27 American Health Packaging Recalls Single Lot of Dronabinol Capsules Dronabinol FDA
2010-10-27 Teva Recalls a Single Lot of Claravis Capsules Isotretinoin FDA
2010-10-27 Fresenius Recalls Single Lot of PhosLo GelCaps Calcium Acetate FDA
2010-10-27 Apotex Corp Recalls Single Lot of Oxybutynin Oral Solution Oxybutynin FDA
2010-10-28 FDA Issues Reminder to Avoid Concomitant Use of Plavix (Clopidogrel) and Omeprazole (Prilosec, Prilosec OTC, Zegerid, Zegerid OTC) Clopidogrel FDA
2010-10-28 Sanofi-Aventis Recalls Single Lot of Apidra SoloStar Insulin Glulisine FDA
2010-10-29 Sandoz Issues Voluntary Recall of Methotrexate Injection Vials Methotrexate Manufacturer
2010-10-31 Pfizer Recalls Two More Lots of Lipitor 40 mg Tablets Due To Strange Smell Atorvastatin Manufacturer