Coumadin Recall Issued Due to Risk Of High Potency Tablets

Potentially defective and extra strength tablets of Coumadin, which could lead to a potentially life-threatening blood thinner overdose, has resulted in the recall for one lot of the medication by Bristol-Myers Squibb. 

The Coumadin recall was announced by the FDA on Monday after a pill tested by Bristol-Myers Squibb was found to have too high a potency, which could potentially cause a Coumadin overdose.

Coumadin (warfarin) is a popular blood thinner used for prevention of blood clots and embolisms. However, receiving too much of the blood thinner could lead to an increased risk of bleeding in patients. There have been no adverse event reports related to the recalled Coumadin.

The recall affects one lot of Coumadin Crytstalline 5 mg tablets in 1,000-count bottles. The recalled bottles have a lot number of 9H49374A and are distributed via prescriptions in smaller quantities. The recalled pills have an expiration date of September 30, 2012.

Patients taking 5 mg Coumadin should continue to take the drug, but should contact their pharmacist to make sure their pills are not from the recalled lot. If their pills were affected by the Coumadin recall, they should contact their health care provider for medical advice, the manufacturer warns.

This is the second Coumadin recall in less than a year. In July 2010, Bristol-Myers Squibb recalled three lots of 1 mg Coumadin after determining that the effectiveness of the pills changed over time due to poor quality isopropanol, which keeps Coumadin’s active ingredient in a crystalline state.

Any adverse reactions should be reported to the FDA’s MedWatch adverse events reporting program at www.fda.gov/medwatch.