Bristol-Myers Squibb has confirmed its initiation of a voluntary recall of blister pack physician samples of warfarin (Coumadin) 1 mg (blisters of 10), as well as Coumadin 1 mg hospital unit dose blister packs of 100, because the lots may not meet specification 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.
According to the FDA, 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.
This recall is being conducted with the knowledge of the FDA and is limited to the specific lots, dosage and blister packaging, Christina Trank, spokesperson from BMS, told Cardiovascular Business News, in an email.
Affected lots for the physician samples are 9A48931A, 9A48931B and 9A48931C with an expiry date of January 2012. The New York City-based company also said the affected lots for the hospital unit dose blister packs are 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
Trank said that there have been no reports of adverse events related to this issue.