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Recalls, market withdrawals, & safety alerts > bristol-myers squibb initiates a nationwide voluntary recall of coumadin (r) 1 mg tablet blister packs
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Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® 1 mg Tablet Blister
-Recall Involves 1 mg Physician Sample Blister Packs and 1 mg Hospital Blister Packs Only-
FOR IMMEDIATE RELEASE
-- July 12, 2010 - Bristol-Myers Squibb initiates a voluntary recall of 3 lots of
physician sample blister packs of Coumadin® 1 mg tablets and 5 lots, of Coumadin 1 mg tablet hospital unit
dose (HUD) blister packs. The following lot numbers are included in this recall: 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. The recall is a
precautionary measure based upon the company’s determination that some of the tablets, over time, may not
meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the
crystalline state, and could affect the therapeutic levels of the active ingredient.
Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of
clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased
risk of bleeding.
The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve
Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may
have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is
To date, the company has not received any reports of adverse events related to this issue. Bristol-Myers Squibb
is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The
company has notified the U.S. Food and Drug Administration (FDA), and has issued recall communications to allphysicians 9 and other customers 10 involved.
Any adverse reactions may also be reported 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 atwww.fda.gov 11.
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