MUMBAI, July 3 (Reuters) - India’s Sun Pharmaceutical Industries Ltd is recalling 200 vials of the chemotherapy drug gemcitabine in the United States due to a lack of assurance of sterility, the U.S. Food and Drug Administration said on Thursday.
The drug being recalled was manufactured by Sun Pharma's unit Caraco Pharmaceutical Laboratories Ltd at its plant in the western Indian state of Gujarat, the FDA said in a post on its website. (1.usa.gov/1o3E8fS)
The voluntary recall was initiated in April and was classified by the FDA as Class II, meaning that use of or exposure to the recalled drug may cause temporary or medically reversible adverse health consequences.
This marks Sun Pharma’s second drug recall this year. In January, the company started a voluntary recall of about 2,528 bottles of its generic version of diabetes drug Glumetza, after it received a customer complaint that one of the bottles contained tablets of an epilepsy drug. (Reporting by Zeba Siddiqui in Mumbai; Editing by Sunil Nair)