D-1095-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 23, 2017
- Initiation Date
- July 20, 2017
- Termination Date
- February 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5664 bottles
Product Description
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
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 Pattern
NJ
Code Information
Lot # ENT17008, Exp 01/2019