Ranbaxy recalls skin infection drug from US market
The country's largest drug maker, Ranbaxy Laboratories Ltd, has recalled Sotret Isotretinoin, a skin infection drug, from the US market, in lines with its move to withdraw all drugs that fall under US Food and Drug Administration's (US FDA) Class III category.
It had, earlier, recalled Nitrofurantoin - a drug for urinary tract infection - from the US, as it could not prove its conformity with US health laws. Also in November 2007, it failed to prove the purity of gabapentin tablets as per US laws, and was forced to withdraw 73 million gabapentin tablets from the US market.
The company said in a statement: "Ranbaxy Laboratories Inc, Princeton, NJ, is conducting a voluntary recall of Sotret Isotretinoin Capsules, USP 40mg, which is limited to lot no 1876846 currently available in the US market."
The company has conducted all required tests on these drugs and has found their conformity with the specification laid down by the US drug agency. However, it has decided to withdraw drugs under extra precautionary measures, in the backdrop of its commitment to deliver safe and healthy products for patients.
The company, with annual sales of around $415 million in the US market, started selling drugs in the US in 2003, after getting necessary approval from FDA.