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Sun Pharmaceutical Industries Ltd has voluntarily recalled 200 vials of its cancer drug, gemcitabine, in the United States. This was because of lack of assurance of sterility of the vials, informed US Food and Drug Administration (USFDA) on Thursday.
The drug was manufactured by the pharma’s giant’s Gujarat unit, Caraco Pharmaceutical Laboratories Ltd, informs the USFDA website.
The recall was initiated in April and USFDA classified the drug as Class II, which means its use may cause temporary or medical reversible adverse health consequences.
This is the second time the company has recalled its product in 2014. Earlier, Sun Pharma initiated voluntary recall of around 2,500 bottles of generic version of diabetes drug, Glumetza.
In April, Sun Pharma had announced the acquisition of Ranbaxy Laboratories Ltd. Ranbaxy, which is one of the biggest generic drug makers of India, had recently been questioned by the US authorities for not meeting “good manufacturing practices’ norms.
The year has been a happening one for Sun Pharma, which also settled a pact with Novartis Pharmaceutical Corporation, for its cancer drug Gleevec. The company can launch a generic version of medicine in US from 2016.