FDA Issues Recall of 200 Vials of Sun Pharma’s Chemo Drug

The US Food and Drug Administration has announced that it has recalled around 200 vials of a chemotherapy drug manufactured by Indian pharma giant Sun Pharmaceuticals Industries. The drug in question is gemcitabine and the FDA revealed that it has recalled the vials as they have been manufactured at Sun Pharma’s Caraco Pharmaceutical Laboratories Ltd. plant in Gujarat, which the health regulator claimed does not abide by its sterility standards and hence the vials’ safety cannot be assured.

This is the third time that Sun Pharma has fallen foul of the FDA this year with the health regulator issuing an import ban on the company’s Karkhadi plant in Gujarat after finding it not up to the standards while Sun Pharma had issued a voluntary recall of over 2,500 bottles of Glumetza back in January.



Source-Medindia