Drug product
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
D-0001-2026
Product summary
- Event
- Event 97684
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 912 30-count bottles
- Official record key
drug-enforcement:D-0001-2026
Official wording
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Code information: Lot#: E409308, Exp 12/31/2026
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification