Bristol-Myers Squibb Expands Voluntary Recall of COUMADIN® Tablets (Warfarin Sodium Tablets, USP) Crystalline to Retail/ Dispensing Level to Include Certain Lots of 2.5 MG, 4 MG, 7.5 MG, and 10 MG Tablets

Bristol-Myers Squibb Company is expanding its May 2, 2011 voluntary recall of one lot of COUMADIN® Tablets (Warfarin Sodium Tablets, USP) Crystalline 5 mg, to include an additional 29 lots of 100, 250 and 1,000-count bottles, blister packs and hospital unit dose packs which include 2.5 mg, 4 mg, 7.5 mg and 10 mg tablets. Bristol-Myers Squibb is recalling 17 lots in the U.S. and Puerto Rico, and a total of 12 lots distributed in Canada, Chile, Colombia, Mexico, Saudi Arabia and United Arab Emirates to the dispensing level. The company has notified the U.S. Food and Drug Administration (FDA) and is informing regulatory health authorities in the affected countries about the recall.

Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately.

The previous recall initiated May 2, 2011 was based on the company’s testing of tablets from a COUMADIN 5 mg bottle in which a single tablet was found to be higher in potency than expected. The company has determined that the same lot of active ingredient used in the previously recalled COUMADIN 5 mg tablet lot was used in the additional 29 lots being recalled (lot numbers listed below). To date, no out-of-specification test results have been identified for the lots being recalled; however, the company is conducting the recall as a precautionary measure.

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; whereas an increase of active ingredient may increase the risk of bleeding. Given the current findings, the probability of either scenario occurring appears to be very low.

Patients should not interrupt their COUMADIN therapy and should consult their healthcare providers if they have any questions regarding their treatment.

For Physicians and Pharmacists in the U.S. and Puerto Rico
Physicians and pharmacists who have specific questions about the expanded recall, please utilize the following numbers:

Recall Logistics: Stericycle
1-866- 792-5448
General and Medical Inquiries: Bristol-Myers Squibb Customer Relations
1-800-332-2056 (option 1, then option 4)
U.S. Reimbursement Process: Bristol-Myers Squibb Customer Service Operations
1-800-631-5244 (option 1, then option 5)
Puerto Rico Reimbursement Process: 1-787-792-6624
BMS Patient Assistance Foundation: 1-800-736-0003 (Option 9)


Any adverse reactions may 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 at www.fda.gov.

The specific lots and dosage strengths being recalled in the U.S. and Puerto Rico are listed below:



Strength Lot Number Description NDC Expiration
2.5 mg 9J51678A COUMADIN TAB 2.5MG (1BTLX1000) US 0056-0176-90 31-Oct-2012
2.5 mg 9J51681C COUMADIN TAB 2.5MG (1BTLX100) US 0056-0176-70 31-Oct-2012
2.5 mg 9J51684B COUMADIN TAB 2.5MG (1BTLX100) US 0056-0176-70 31-Oct-2012
2.5 mg 9J51686D COUMADIN TAB 2.5MG (1BTLX1000) US 0056-0176-90 31-Oct-2012
2.5 mg 9K52102A COUMADIN TAB 2.5MG (1BTLX100) US 0056-0176-70 31-Oct-2012
4 mg 9J54837B COUMADIN TAB 4MG (1BTLX1000) US 0056-0168-90 31-Oct-2012
4 mg 9J54837C COUMADIN TAB 4MG (10BLPX10) HUD US 0056-0168-75 31-Oct-2012
4 mg 9J54843A COUMADIN TAB 4MG (1BTLX100) US 0056-0168-70 31-Oct-2012
4 mg 9J54846A COUMADIN TAB 4MG 1BTLX1000) US 0056-0168-90 31-Oct-2012
7.5 mg 9J49837A COUMADIN TAB 7.5MG (1BTLX100) US 0056-0173-70 31-Oct-2012
7.5 mg 9J49837B COUMADIN TAB 7.5MG (10BLPX10) HUD US 0056-0173-75 31-Oct-2012
7.5 mg 9J49839B COUMADIN TAB 7.5MG (1BTLX100) US 0056-0173-70 31-Oct-2012
7.5 mg 9J49839C COUMADIN TAB 7.5MG (10BLPX10) HUD US 0056-0173-75 31-Oct-2012
10 mg 9J53293C COUMADIN TAB 10MG (1BTLX100) US 0056-0174-70 31-Oct-2012
10 mg 9J53293D COUMADIN TAB 10MG (10BLPX10) HUD US 0056-0174-75 31-Oct-2012
10 mg 9J53293F COUMADIN TAB 10MG (1BTLX100) US 0056-0174-70 31-Oct-2012
10 mg 9K50111A COUMADIN TAB 10MG (1BTLX100) US 0056-0174-70 31-Oct-2012
Dates of Distribution: December 2009 - May 2011


For Physicians and Pharmacists in Canada, Chile, Colombia, Mexico, Saudi Arabia and United Arab Emirates
Physicians and pharmacists who have specific questions about the expanded recall, please utilize the following numbers:

Canada: 1-800-267-0005
Chile: +123-0-020-5542
Colombia: +01-800-5-1-81061
Mexico: +001-888-226-5075 (International Lada 800)
+5337-2955 (Local Mexico City)
Saudi Arabia &
United Arab Emirates: 		+96614601534, Extension 4127

The specific lots and dosage strengths being recalled in Canada, Chile, Colombia, Mexico, Saudi Arabia and United Arab Emirates are listed below:

Strength Lot Number Description Market Expiration
2.5 mg 9J51686E COUMADIN TAB 2.5MG (3BLPX10) MX Mexico 01-Oct-2012
2.5 mg 9J51686C COUMADIN TAB 2.5MG (1BTLX100) CA Canada 31-Oct-2012
2.5 mg 0A0472 COUMADIN TAB 2.5MG (3BLPX10) CL Chile 31-Oct-2012
2.5 mg 9J51684A COUMADIN TAB 2.5MG (1BTLX250) CA Canada 31-Oct-2012
2.5 mg 9J51681F COUMADIN TAB 2.5MG (1BTLX100) GEM United Arab Emirates 01-Oct-2012
2.5 mg 9J51681D COUMADIN TAB 2.5MG (1BTLX100) SA Saudi Arabia 01-Oct-2012
2.5 mg 9J51681A COUMADIN TAB 2.5MG (3BLPX10) MX Mexico 01-Oct-2012
2.5 mg 0A0483 COUMADIN TAB 2.5MG (3BPLX10) XSP Colombia 31-Oct-2012
4 mg 9J 54837A COUMADIN TAB 4MG (1BTLX250) CA Canada 31-Oct-2012
7.5 mg 9J49839D COUMADIN TAB 7.5MG (1BTLX100) SA Saudi Arabia 30-Sep-2012
7.5 mg 9J49839E COUMADIN TAB 7.5MG (1BTLX100) SA Saudi Arabia 30-Sep-2012
10 mg 9J53293A COUMADIN TAB 10MG (1BTLX100) CA Canada 31-Oct-2012
Dates of Distribution: December 2009 - May 2011