COUMADIN® Tablets (Warfarin Sodium Tablets, USP) Crystalline
As of October 25, 2011
Bristol-Myers Squibb takes the quality and safety of its products very seriously. We are committed to patients’ safety first and to the safest and most effective use of all of our products.
As such, Bristol-Myers Squibb is initiating a voluntary recall at the retail/dispensing level of the following 3 COUMADIN tablet lots in the US:
|
Strength
|
Lot Number
|
Description
|
NDC
|
Expiration
|
|
5 mg
|
0A64654A
|
COUMADIN TAB 5MG (10BLPX10) HUD US
|
0056-0172-75
0056-0172-01
|
31-Mar-13
|
|
5 mg
|
0D55407A
|
COUMADIN TAB 5MG (10BLPX10) HUD US
|
0056-0172-75
0056-0172-01
|
30-Apr-13
|
|
2 mg
|
0B60594A
|
COUMADIN TAB 2MG (10BLPX10) HUD US
|
0056-0170-75
0056-0170-01
|
30-Apr-13
|
Dates of distribution: July 2010 – March 2011
|
This recall is not for patients and is being initiated based on test results which identified the product may not conform to specification throughout the shelf-life. To date, no out-of-specification test results have been identified for the lots listed above. This recall is being conducted as a precautionary measure.
This recall is being conducted to the retail/dispensing level with the knowledge of the U.S. Food and Drug Administration, and is limited to the specific lot and dosage mentioned. The markets impacted are the U.S., Puerto Rico, Saudi Arabia, UAE, Kuwait, Qatar, Oman, Dubai, Abu Dhabi, Bahrain and Taiwan.
COUMADIN is prescribed to treat blood clots and lower the chance of blood clots forming in the body. A change in Coumadin’s specifications may result in changes in drug responses in some patients, therefore increases the risk of clots or bleeding. However, given the current findings, the probability of either of these scenarios occurring is very low.
Patients who have been prescribed COUMADIN tablets should not interrupt their therapy. For questions, regarding treatment, patients should consult their healthcare provider. For any other questions, customers can call the Bristol-Myers Squibb customer relations center 1-800-332-2056 (option 1, then option 4).