November 26, 2012 — Ranbaxy Pharmaceuticals Inc. has recalled 41 lots of generic Lipitor (atorvastatin calcium) because the product may contain particles of glass less than 1-mm in size. No injuries have been reported. The recall may cause a drug shortage of generic Lipitor, because about 1 million prescriptions are filled every week, and Ranbaxy is a major supplier of the drug.
According to a statement from Ranbaxy:
“Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for atorvastatin calcium tablets, in connection with its 10 mg 20 mg and 40 mg dosage strengths, packaged in 90’s and 500 count bottles and only with respect to certain select lot numbers. The recall does not affect or relate to the 80 mg strength.”
The recall occurred just 7 months after the U.S. Food and Drug Administration (FDA) un-banned Ranbaxy from selling medications in the U.S. The FDA banned 30 products from the country in 2008, after they found manufacturing problems in the company’s New Delhi facilities that didn’t meet FDA standards. Ranbaxy was also accused of misrepresenting data sent to the FDA. In December 2011, Ranbaxy signed a 5-year agreement with the FDA and the Department of Justice to comply with improved manufacturing practices.
Lipitor is a popular cholesterol-lowering medication that was created by Pfizer, Inc. After the patent on Lipitor expired last November, several generic drug companies began manufacturing generic versions of the drug. Ranbaxy, Watson Pharmaceuticals, and Mylan all produce generic versions of Lipitor.