India's leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be 'out of specification'.This is the second instance in four months when Ranbaxy has initiated a recall. In July, the company had pulled out a lot of Sotret from the US market after it was found to be degraded.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India and included acne drug Sotret, epilepsy and nerve pain drug gabapentin and antibiotic ciprofloxacin.
While Ranbaxy tested the lot in question and found it to have met the specified standards, it is recalling the product on the US health regulator Food and Drug Administration's recommendation, the company said.
Ranbaxy Laboratories, India's biggest drugmaker, may lose as much as $140 million of revenue in 2009 after the US drug regulator blocked sale of more than 30 generic medicines and 7 APIs made in two factories of the company, according to analysts.
Ranbaxy Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.
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