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news.Bristol-Myers Squibb is voluntarily taking back 3 lots of physician sample blister packs of Coumadin 1mg tablets and 5 lots of Coumadin 1mg tablet hospital unit dose (HUD) blister packs in the US.
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Bristol-Myers informed that the lot numbers which are included in the recall are Physician Sample Blister Packs: Lot no 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot no 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
The recall is a precautionary measure taken by Bristol-Myers based on its determination that some of the tablets, over time, may not meet specification for isopropanol.
Isopropanol 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.
Bristol-Myers stated that the recall includes only Coumadin 1mg tablet blister-packs distributed in the US and does not include Coumadin 1mg supplied in bottles or any other strengths and dosage forms of the product.
Bristol-Myers cautioned patients having the recalled lot to contact their physicians to ensure that their anticoagulation therapy is not interrupted.
Bristol-Myers added that to date, it has not received any reports of adverse events related to this issue. The company has notified the FDA, and has issued recall communications to all physicians and other customers involved.