FDA recall D-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

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.

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2017-07-20

Report date

2017-08-23

Termination date

2019-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1095-2017