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

Recall Number: D-1095-2017

Firm: Hetero USA Inc

Classification: Class II

Status: Terminated

Report Date: 20170823

Initiation Date: 20170720

Termination Date: 20190227

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

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