Ranbaxy recalls 64,000 bottles of generic Lipitor

Reuters/MumbaiDrugmaker Ranbaxy Laboratories Ltd, reeling under a flurry of regulatory rebukes due to poor quality, has recalled more than 64,000 bottles of the generic version of a cholesterol-lowering drug in the US after dosage 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 20mg tablet in a sealed bottle marked for 10mg 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 Company 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 yesterday. 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 US, its biggest market. Ranbaxy-owned Ohm Laboratories Inc in New Jersey is now the company’s only permitted maker of drugs for US sale. Worries about quality control in India’s $14bn drug industry have come to the fore in the past year as plants run by Ranbaxy and local rival Wockhardt Ltd have been banned after falling short of the FDA’s “good manufacturing practices.” India’s drugmakers have come under closer scrutiny as the FDA, the guardian of the world’s most important pharmaceuticals market, has increased its presence in the country, reflecting India’s growing importance as a supplier to the US.