Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® 1 mg Tablet Blister Pack

Recall Involves 1 mg Physician Sample Blister Packs and 1 mg Hospital Blister Packs Only

Bristol-Myers Squibb has initiated a voluntary recall of three lots of physician sample blister packs of Coumadin® 1 mg tablets and five lots of Coumadin 1 mg tablet hospital unit dose blister packs. The following lot numbers are included in this recall:

• Physician Sample Blister Packs, expiration January 2012:
  • Lot# 9A48931A
  • Lot# 9A48931B
  • Lot# 9A48931C
• Hospital Unit Dose Blister Packs, expiration dates between June 2011 and November 2012:
  • Lot# 8F34006B
  • Lot# 8K44272A
  • Lot# 8K46168A
  • Lot# 9F44437A
  • Lot# 9K58012B

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. 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 not interrupted.

• Communication to Physicians Regarding Coumadin 1 mg Physician Sample Blister Packs —
  Read Physician Sample recall letter (PDF, 16K)
• Communication to Customers Regarding Coumadin 1 mg Hospital Unit Dose Blister Packs —
  Read Hospital Unit Dose recall letter (PDF, 19K)
• Coumadin (warfarin sodium) Prescribing Information (PDF, 172K)

To date, the company has not received any reports of adverse events related to this issue. Bristol-Myers Squibb states that it 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 all physicians and other customers 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.

Healthcare professionals and customers may telephone the following numbers for assistance if they have further questions about the recall:

Recall Logistics:	Stericycle 1 (877) 546-0128
General Inquiries:	Bristol-Myers Squibb Customer Relations 1 (800) 332-2056 (option 1, then option 4)
Medical Inquiries:	Bristol-Myers Squibb Medical Information 1 (800) 321-1335 (option 5)
Recall Reimbursement Process:	Bristol-Myers Squibb Customer Service Operations 1 (800) 631-5244 (option 1, then option 5)