Reported Aug 23, 2017 · Terminated
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc.,…
Hetero USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hetero USA Inc · 1035 Centennial Ave · Piscataway, NJ · 08854-4124
Is this the product you have?
Entecavir Tablets 0.5 mg30 tablets per containerRx Only
- Manufactured forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854
- ByHetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
- Lot codes and dates
Lot # ENT17008Exp 01/2019
- Amount recalled
- 5664 bottles
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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