07/14/2010 // WPB, FL, USA // Nicole Howley // Nicole Howley
West Palm Beach, FL—A voluntary recall of 3 lots of physician sample blister packs of Coumadin® 1 mg tablets and 5 lots, of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs, has been initiated by Bristol-Myers Squibb. The U.S. Food and Drug Administration (FDA) released the recall on July 12, 2010.
The recall included: 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 recall was initiated as a precautionary measure after Bristol-Myers Squibb determined that some of the tablets, over a period of time, would not meet the specification for isopropanol. This could affect the therapeutic levels of the active ingredient, Coumadin.
The FDA press release stated, “Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and 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. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.”
Any adverse reactions can 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.
Consumers and healthcare professionals can obtain more information about the recall at:
• 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)
Legal News Reporter: Nicole Howley-Legal news for product safety attorneys.