Blister Packs of Coumadin Recalled

Some tablets may no longer meet specifications for stabilizing ingredient
By Monica Smith
HealthDay Reporter

THURSDAY, July 15 (HealthDay News) -- Bristol-Myers Squibb has initiated a voluntary recall of physician sample blister packs and hospital unit dose (HUD) blister packs of Coumadin, a medication used to treat or prevent blood clots.

The company determined that, over time, some tablets may lose specifications for isopropanol, an ingredient that keeps the medication's active ingredient in a crystalline state, which could have an effect on its therapeutic properties. A decrease in the active ingredient could raise the risk of blood clots, possibly leading to heart attack and stroke, whereas an increase in the active ingredient raises the risk of bleeding.

Only U.S.-distributed Coumadin 1 mg tablets in blister packs -- not in bottles, or other strengths or dosage forms -- are involved in the recall. The recall includes the following lot numbers for physician sample packs: 9A48931A, 9A48931B, 9A48931C, expiring January 2012; and for HUD blister packs: 8F34006B, 8K44272A, 8K46168A, 9F44437A, and 9K58012B, expiring June 2011 to November 2012.

According to the company's physician-notification letter, the "medical assessment of this situation indicates that there does not appear to be a clinically important risk related to Coumadin 1 mg tablets in regard to isopropanol level. However, use of tablets with low isopropanol could, in some cases, potentially lead to patient-to-patient variation in bioavailability. All other product characteristics, including warfarin sodium assay, are within specification."

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