Coumadin 1-mg tablet blister packs recalled

July 20, 2010

A 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 has been initiated by Bristol-Myers Squibb.

A 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.

This recall includes: Physician Sample Blister Packs (Lot # 9A48931A, 9A48931B, 9A48931C, expiration January 2012) and HUD Blister Pack (Lots # 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B, with expiry dates between June 2011 and November 2012).

The recall is based on the company’s 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.

A decrease of active ingredient may increase the risk of blood 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 involves only Coumadin 1- mg tablet blister packs distributed in the United States. This recall does not involve Coumadin 1-mg tablets supplied in bottles or any other strengths or dosage forms of the product. Patients who possess product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.