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FDA: Manufacturer recalls 200 vials of gemcitabine from US market
The FDA recently announced that Sun Pharmaceutical Industries is recalling 200 vials of the chemotherapy drug, gemcitabine, in the United States due to a lack of assurance of sterility.
The drug being recalled was manufactured by Sun Pharmaceutical's unit Caraco Pharmaceutical Laboratories unit at its plant in Gujarat, the FDA reported in a post on its website.
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 Pharmaceutical'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.