Bristol-Myers recalls 1.5 Million Coumadin sample tablets

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J&J dealing with multiple recalls of Tylenol, Benadryl and, here is another company in news for recalling its product. Bristol-Myers Squibb, a global Biopharma company has initiated nationwide voluntarily recall of eight production lots of anti-clotting drug, Coumadin. The recall is a preventive measure and company has not disclosed the root cause of the problem.

What is Coumadin used for?
Coumadin, which is also called warfarin is a blood thinning agent.  It is used to treat or prevent blood clots after surgery.

Why Bristol-Myers recalled the Coumadin?
Bristol-Myers reported that amount of isopropanol in Coumadin tablets could change over time. Isopropanol, or isopropyl alcohol, is used to keep the drug’s active ingredient in a crystalline state. The changing levels of isopropanol could increase or reduce the amount of the active ingredient in the tablets that can pose either a greater risk of blood clotting or bleeding.

Were there any side effects reported so far?
Bristol-Myers Squibb says that recall is a precaution and no side effects have been reported till date.

Bristol-Myers Squibb is recalling five production lots of Coumadin hospital unit doses and three lots of physician...



samples. The recall includes a total of 1.5 million 1-milligram tablets available in blister packs. Bottled product is safe to use.

Lot No. of recalled products
Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012.

HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.

If you have been prescribed Coumadin by your doctor, please check the lot no. before taking another pill. If you have any adverse reactions, you may report to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov.

Source: drugwatch

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