Coumadin 1-mg Unit Dose Packs Recalled by BMS

Cheryl A. Thompson

BETHESDA, MD 13 July 2010—Bristol-Myers Squibb on Monday announced a recall of eight lots of Coumadin 1-mg tablets in blister packs intended for use in hospitals or as samples.

Five of the lots are 100-tablet unit dose packs: 8F34006B, 8K44272A, 8K46168A, 9F44437A, and 9K58012B. These lots have an expiration date between June 2011 and November 2012 and were distributed September 2008 through April 2010.

The other lots in the recall are 10-tablet blister packs: 9A48931A, 9A48931B, and 9A48931C. These lots were distributed July 2009 through April 2010 by company sales representatives and through a direct-mail sample program to physicians.

The company said some of the tablets in the lots may eventually not contain the required amount of isopropanol to maintain warfarin, the active ingredient, in the crystalline state. Amorphous warfarin, according to the labeling for Coumadin, has trace impurities.

Hospitals and other purchasers of the 100-count unit dose packs are being asked to return their remaining inventory of the five lots to Stericycle for credit. Stericycle, available at 877-546-0128, is handling all returns of tablets affected by the recall, including the sample packs. Questions about the reimbursement process for the recall should be directed to Bristol-Myers Squibb Customer Service Operations at 800-631-5244 (select option 1, then option 5).

At the time of the announcement, the company said it had not received any reports of adverse events related to the isopropanol issue.