Zydus Pharmaceuticals (USA) Inc, a unit of Ahmedabad-based drugmaker, is recalling 8,784 bottles of antiviral drug Entecavir tablets, due to “failed impurity/ degradation specifications,” the USFDA stated.
The company initiated the Class II recall on September 4.
Another drug firm Unichem Pharmaceuticals USA Inc is recalling 230 90-count bottles for label mix-up, the USFDA said.
The East Brunswick-based firm issued the Class I recall on August 27, it added.
India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.
