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Sun Pharma, Ranbaxy Face U.S. Recalls

March 11, 2014

Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report.

Sun Pharma initiated a recall of 2,528 bottles of its metformin HCl extended-release tablets manufactured in Mumbai and distributed by Detroit’s Caraco Pharmaceuticals, after a customer discovered Gabapentin (neurontin) tablets instead.

The Ranbaxy recall stems from a pharmacist’s discovery of a 20-mg atorvastatin calcium pill in a bottle that was supposed to contain 10-mg doses. It affects 64,626 bottles manufactured in Jacksonville, Fla.

This is not the first time that Ranbaxy has faced quality issues in the recent past. The drugmaker is currently operating under a 2012 consent decree that earlier this year added Ranbaxy’s Toansa, India, plant to the list of facilities facing stricter oversight.

The quality of Indian pharmaceutical products has been a hot-button topic. FDA Commissioner Margaret Hamburg visited the subcontinent just last month, where she met with Indian officials and drug industry representatives and signed a five-year accord whereby the two countries would share data from inspections of clinical sites, labs and manufacturing plants. — Lena Freund

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