July 2, 2010 (Princeton, NJ) — Bristol-Myers Squibb has voluntarily recalled a number of blister packs of its anticoagulant warfarin, Coumadin, 1 mg, provided as samples to physicians and hospitals. The recall is a precautionary measure, based upon the possibility that some of the tablets included may not contain the correct amount of isopropanol, an additive required to maintain the active ingredient in a crystalline state.

"Our medical assessment indicates that there does not appear to be a clinically important risk related to Coumadin 1-mg tablets in regard to isopropanol level," the company said in a statement provided to heartwire . Use of tablets with low isopropanol could lead to patient-to-patient variation in bioavailability, it notes, but "there have been no reports of adverse events related to this issue."

The affected lots include physician samples labeled 9A48931A, 9A48931B, and 9A48931C, with an expiration date of January 2012, and hospital unit dose (HUD) blister packs 8F34006B, 8k44272A, 8K46168A, 9F44437A, and 9K58012B, with expiration dates between June 2011 and November 2012. The recall affects only the US market and is being conducted with the knowledge of the FDA.


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