Ranbaxy recalls generic Lipitor in US market over glass particles in bottles

Ranbaxy Laboratories, the Indian unit of Japan's Daiichi Sankyo, yesterday recalled some batches of its generic version of cholesterol-lowering drug Lipitor from the US market after finding small glass particles in some lots of Atorvastatin, the generic name for Pfizer's blockbuster drug Lipitor.

Ranbaxy's US subsidiary, Ranbaxy Pharmaceuticals Inc, is recalling certain select lot numbers of Atorvastatin calcium tablets of 10mg, 20mg, and 40mg dosage strengths, packaged in 90's and 500 count bottles. The recall does not affect the 80mg strength dosage.

Ranbaxy, the Indian unit of Japan's Daiichi Sankyo said that the voluntary recall would cause a temporary supply disruption, but it expects to resume shipments after conducting an internal probe within two weeks.

The company did not reveal how it discovered the problem nor did it report any injuries or deaths tied to the recalled product.

Ranbaxy was the first to market the generic version of Lipitor late last year after Pfizer lost Lipitor's US patent protection on 30 November 2011, and Ranbaxy was given rights to 180 days of marketing exclusivity by the US Food and Drug Administration (FDA) for being the first to file for a generic equivalent.

Ranbaxy and US-based Watson Pharmaceuticals, which had been authorised by Pfizer to sell a generic version of Lipitor, were the two companies that had exclusive rights to sell the generic version of Lipitor for six months in the US.