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Pharmaceuticals / Quality / Regulatory Affairs / GMPs / Postmarket Safety / Commercial Operations

Sun Pharma, Ranbaxy Face U.S. Recalls

March 11, 2014
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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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