FDA-Drug2017-08-23Class II
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
Hetero USA Inc
Hazard
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Sold states
NJ
Affected count
5664 bottles
Manufactured in
1035 Centennial Ave, N/A, Piscataway, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1095-2017Don't want to check this manually?
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