ST LOUIS (MD Consult) - On July 12, 2010, Bristol-Myers Squibb (BMS) announced that it is conducting 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 blister packs that have been distributed in the United States. This recall does not involve Coumadin 1-mg tablets supplied in bottles, nor does it involve any other strengths and dosage forms of the product.
The lot numbers for the recalled products are the following: 9A48931A, 9A48931B, and 9A48931C for the sample packs; and 8F34006B, 8K44272A, 8K46168A, 9F44437A, and 9K58012B for the hospital packs. Expiration dates on the recalled products range from June 2011 to November 2012.
The manufacturer determined that some of a product (isopropanol) used in the tablets to maintain the active ingredient (coumadin) in a crystalline state may not meet certain specifications. Theoretically, this issue could create variance in therapeutic levels of the active ingredient in persons taking the drug. A decrease in the level of the active ingredient could increase the risk of thrombosis, which could lead to myocardial infarction or stroke. An increase in the level of the active ingredient could heighten the risk for hemorrhage.
To date, BMS has not received any reports of adverse events related to this issue.
Medical inquiries about the recall can be directed to BMS by telephoning 1-800-321-1335 (option 5). Any adverse reactions may be reported to the MedWatch Program of the US Food and Drug Administration.
