Coumadin Recalled by Bristol-Myers SquibbJul 13, 2010 | Parker Waichman LLP
Bristol-Myers Squibb, the maker of the blood thinner, Coumadin,has implemented a voluntary recall of three lots of physician sample blister packs of Coumadin® 1 mg tablets and five lots, of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs, the U.S. Food and Drug Administration (FDA) just announced.
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 FDA said that the recall is a precautionary measure based on the company’s determination that some of the tablets, over time, may not meet specifications for isopropanol, which is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient.
Coumadin is prescribed to treat or prevent blood clots. A decrease of the active ingredient may increase the risk of clots, which could lead to heart attack or stroke. If there is too much active ingredient, there is an increased risk of bleeding.
The recall only involves Coumadin 1 mg tablet blister packs distributed in the U.S. and does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have the recalled product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted. To date, the company has not received any reports of adverse events related to this issue.
Bristol-Myers Squibb has connection recall communications to all physicians and other customers involved.
Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov.
Healthcare professionals and customers may also call the following for additional recall assistance:
• Recall Logistics: Stericycle 1-877-546-0128
• General Inquiries: Bristol-Myers Squibb Customer Relations 1-800-332-2056 (option 1, then option 4)
• Medical Inquiries: Bristol-Myers Squibb Medical Information 1-800-321-1335 (option 5)
• Recall Reimbursement Process: Bristol-Myers Squibb Customer Service Operations 1-800-631-5244 (option 1, then option 5)