Bristol-Myers Squibb has issued a voluntary recall of one lot of its 1,000-count bottles of Coumadin (warfarin) 5 mg tablets after the company found that one tablet had higher doses than expected.
The New York City-based Bristol-Myers said the lot affected is 9H49374A and has an expiration date of Sept. 30, 2012. The FDA said that an overabundance of the active ingredient could increase the risk of bleeding while a decrease of the active ingredient could increase the risk of clots that could increase MI or stroke
While the company said that patients on warfarin should not discontinue treatment, it recommended that patients check with their pharmacists to see if they were administered the infected lot.
The FDA concluded that clinicians and patients should report any adverse events to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.