Indian drugmaker Ranbaxy Laboratories Ltd, reeling under a flurry of regulatory rebukes due to manufacturing quality concerns, has recalled more than 64,000 bottles of the generic version of a cholesterol-lowering drug in the United States after doseage mix-up was detected.
Ranbaxy recalled tablets of atorvastatin calcium, the generic version of Pfizer Inc's cholesterol fighter Lipitor, after a pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, the US Food and Drug Administration (FDA) said on its website.
Ranbaxy, India's biggest drugmaker by revenue and majority owned by Japan's Daiichi Sankyo Co Ltd, confirmed the recall of select batches of the drug, but said the company had not received any product complaints.
"Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the US FDA," the company said in a statement issued to Reuters on Saturday.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States, its biggest market.
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