Ranbaxy's recall of generic Lipitor in US impacts 41 lots


Drug maker Ranbaxy's recall of its generic version of cholesterol lowering drug Lipitor impacts 41 lots in various strengths due to potential presence of foreign substance.

According to information available on the US Food and Drug Administration (USFDA) website, on November 9, 2012, Ranbaxy Inc initiated a voluntary recall of 41 affected lots of Atorvastatin Calcium tablets (10 mg, 20 mg and 40 mg), which is a solid oral dosage form, upto the retail level.

The recall affects lots which have expiry dates of July 2014 and August 2014.

"The company is taking this voluntary action as a precautionary measure due to the fact that we cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size)," Ranbaxy Inc said in a statement.

The recall does not affect or relate to the 80 mg dosage strength of Atorvastatin Calcium tablets.

The probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out, Ranbaxy Inc said.

Last week Ranbaxy had said it was recalling its generic version of cholesterol-lowering drug Lipitor from the US market leading to temporary disruption in the supply.

The Gurgaon-headquartered firm supplies the generic version of Lipitor to the US market from its two facilities -- NewBrunswick based Ohm Laboratories and Mohali plant in India.

Ranbaxy had launched generic atorvastatin in the US market in December last year after the USFDA gave final approval to market its generic version of Lipitor produced at Ohm Laboratories facility in New Brunswick, New Jersey.

Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy.

In April this year, the company commenced shipping of cholesterol lowering drug, atorvastatin calcium oral tablets from its Mohali SEZ plant in Punjab.

Atorvastatin, the generic equivalent of Pfizer's Lipitor drug, generated large sales in the United States.

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