Drug recall D-1095-2017
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
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.
Lots and codes
Lot # ENT17008, Exp 01/2019
Recall details
- Recalling firm
- Hetero USA Inc, Piscataway, NJ
- Quantity
- 5664 bottles
- Distribution
- NJ
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 20, 2017
- Terminated
- February 27, 2019
Related products
- Entecavir – drug information
- NDC 31722-834 Entecavir · Entecavir Anhydrous 1 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-833 Entecavir · Entecavir Anhydrous .5 mg/1 · Camber Pharmaceuticals, Inc.