IGMPI India

Sun Pharmaceutical Industries Ltdinitiated voluntary recall of 200 vials of the chemotherapy drug Gemcitabine in the United States due to lack of assurance of sterility. The cancer drug being recalled from the US market was manufactured by Sun Pharma's unit Caraco Pharmaceutical Laboratories Ltd at its plant in Gujarat.“Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance,” is the official reason listed for the recall in the FDA enforcement report.

The recall of the chemotherapy drug gemcitabine injection has been classified as Class II by the FDA.As per the US FDA, a Class II recall is given in a situation when the use of or exposure to the recalled drug may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.Since the FDA cannot guarantee whether the drug coming out of the Gujarat plant is completely clean or not, the vials are no longer being sold.

This is the second drug recall initiated by Sun Pharma this year.In January, the company had issued a voluntary recall of about 2,528 bottles of diabetes drug metformin hydrochloride after a customer found some gabapentin tablets, an epilepsy drug used to treat seizures, in one of the bottles.Sun Pharma’s plant in Karkhadi, Gujarat was also hit with an import alert from the FDA in March for not following the standards set by the US FDA.