Recalls / Class II
Class IID-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
- Brand name
- Entecavir
- Generic name
- Entecavir
- Active ingredient
- Entecavir Anhydrous
- Route
- Oral
- NDCs
- 31722-833, 31722-834
- FDA application
- ANDA205740
- Affected lot / code info
- Lot # ENT17008, Exp 01/2019
Why it was recalled
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Recalling firm
- Firm
- Hetero USA Inc
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1035 Centennial Ave, N/A, Piscataway, New Jersey 08854-4124
Distribution
- Quantity
- 5664 bottles
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2017-07-20
- FDA classified
- 2017-08-16
- Posted by FDA
- 2017-08-23
- Terminated
- 2019-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1095-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.