Coumadin Recall

Coumadin Recall

Pills May Have Higher Than Expected Potency

On May 2, 2011, the US Food and Drug Administration (FDA) announced that Bristol-Myers Squibb (BMS) initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets ). 

BMS testing of pills from a returned bottle found a pill to be higher in potency than expected. The lot number affected in the U.S. is 9H49374A with an expiration date of September 30, 2012. With an increase of active ingredient there may be an increased risk of bleeding.

RECOMMENDATION: NBCA  Medical and Scientific Advisory Board Chair, Jack Ansell, MD advised  following FDA guidance that “patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.”

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and

Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

 

 

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