Generic Lipitor Recall Issued by Ranbaxy

Ranbaxy is recalling certain lots of their generic Lipitor version, due to potential contamination with tiny shards of glass, adding to concerns over the manufacturing practices of the generic drug maker. 

The drug manufacturer announced the generic Lipitor recall last week, warning that the action may result in a temporary shortage of the medication in the United States, which fills about 1 million prescriptions for the generic version of the cholesterol drug every week.

Lipitor (Atorvastatin) was first approved by the FDA in December 1996 for use in lowering cholesterol. It is a member of a class of drugs called statins and works by inhibiting an enzyme in the liver that takes part in cholesterol production.

Pfizer manufactures the name brand version of Lipitor, but the patent expired in November 2011. In addition to Ranbaxy, generic versions of Lipitor are also manufactured by Mylan and Watson Pharmaceuticals.

The Ranbaxy recall was issued after it was discovered that the drug may be contaminated with small glass particles, which are approximately less than 1mm in size. Although there have been no reports of injuries or illnesses connected to the recalled Lipitor, affected lots may pose a potential safety risk for consumers.

Due to manufacturing problems, Ranbaxy is only allowed to sell generic Lipitor in the United States, after the FDA banned about 30 of its drugs from the market in this country.

The generic drug maker has also been accused of faking data sent to the FDA. The agency and Ranbaxy reached a consent decree in January, which requires the company to rehabilitate its manufacturing processes until they meet FDA standards.

The generic Lipitor recall affects 41 lots of atorvastin calcium tablets sold in 10mg, 20mg and 40mg dosage strengths in 90 and 500-count bottles. Ranbaxy generic Lipitor sold in 80mg strength is not affected by the recall. A complete list of the affected lots can be found here (pdf).

Prior to the availability of generic equivalents, Prizer issued a series of Lipitor recalls in 2010, due to manufacturing issues that resulted in musty odors that were caused by a pesticide used on wood pallets used to ship the drug.