Innovation
Generic version of Lipitor withdrawn in US after finding of small glass particles
By Finfacts Team
Nov 26, 2012 - 5:28 AM

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Ranbaxy headquarters, Gurgoan, India

Ranbaxy Laboratories Ltd. has recalled more than 40 lots of its generic version of the cholesterol-lowering drug Lipitor from the US market after finding batches containing small glass particles.

The Wall Street Journal reports that Ranbaxy, which is headquartered in India and is owned by Japan's Daiichi Sankyo Co., said the voluntary action would cause a temporary supply disruption, but the company expects to complete an investigation of the matter within two weeks and resume shipments thereafter.

The Food and Drug Administration said the recall could lead to a shortage of atorvastatin, the generic name for Lipitor. "We are doing everything we can to mitigate a shortage, including reaching out to other manufacturers," said Sarah Clark-Lynn, an FDA spokeswoman. "We're monitoring the situation."

The FDA said it wasn't aware of any reports of injuries or deaths tied to the recalled product.

The Journal said Pfizer has lost patent protection of  Lipitor and its sales declined 56% to $3.36bn for the first nine months of 2012. Ranbaxy's generic Lipitor sales covered 44% of the US market for the drug.

Ranbaxy said Friday it is conducting a retail-level recall of certain lots of 90- and 500-pill bottles of atorvastatin, in dosage strengths of 10 milligrams, 20 milligrams and 40 milligrams. The 80-milligram dosage isn't part of the recall.

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