Drug product
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.
D-1584-2014
Product summary
- Event
- Event 69075
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1396 Bottles
- Official record key
drug-enforcement:D-1584-2014
Official wording
Reason: Failed Content Uniformity Specifications.
Code information: Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
Distribution pattern: United States including: OH, HI, NH, MS, IL, TX, CA.
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications