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
Reported: August 23, 2017 Initiated: July 20, 2017 #D-1095-2017
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.
Details
- Recalling Firm
- Hetero USA Inc
- Units Affected
- 5664 bottles
- Distribution
- NJ
- Location
- Piscataway, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hetero USA Inc. Units affected: 5664 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 23, 2017. Severity: Moderate. Recall number: D-1095-2017.
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