Drug product
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
D-1095-2017
Product summary
- Firm
- Hetero USA Inc
- Event
- Event 77846
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5664 bottles
- Official record key
drug-enforcement:D-1095-2017
Official wording
Reason: Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Code information: Lot # ENT17008, Exp 01/2019
Distribution pattern: NJ
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specification