Class II
Terminated
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
- Company
- Hetero Usa Inc
- Recall Initiated
- July 20, 2017
- Posted
- August 23, 2017
- Recall Number
- D-1095-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5664 bottles
- Firm Location
- Piscataway, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Distribution
NJ
Lot / Code Info
Lot # ENT17008, Exp 01/2019
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