Drug product
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
D-0657-2025
Product summary
- Event
- Event 97556
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4440 bottles
- Official record key
drug-enforcement:D-0657-2025
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: Lot E309377, Exp 11/30/2025
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications