FDAFDA · Food and drugs·Recall number D-1095-2017
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
Published August 23, 2017 · Recall initiated: July 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ENTECAVIR
- Manufacturer
- Hetero USA Inc
- Distributor
- NJ
- Lot
- Lot # ENT17008, Exp 01/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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