November 26, 2012 — The pharmaceutical drug company Ranbaxy has issued a massive recall of generic Lipitor (atorvastatin calcium) due to potential contamination with glass particles less than 1-mm in size. Although no injuries have been linked to the defect, Ranbaxy is recalling the product out of an “abundance of caution.” The FDA has warned about a possible drug shortage in the next few weeks, because Ranbaxy is one of the largest suppliers of the drug in the United States.
The company has recalled 41 lots of the drug in 10-mg, 20-mg, and 40-mg doses. The 80-mg version of the product is not being recalled. The recalled lots were sold in bottles containing 90 and 500 pills.
Ranbaxy has been plagued with manufacturing problems in the last few years. The FDA banned Ranbaxy from selling 30 generic medications in the U.S. in 2008. Investigations found that manufacturing standards in the company’s New Delhi facilities did not meet FDA standards. The FDA also found that Ranbaxy may have falsified data that was submitted to the agency.
In December 2011, Ranbaxy entered into a 5-year agreement with the FDA and the Department of Justice. The FDA allowed Ranbaxy to sell certain generic drugs in the U.S. in exchange for improving manufacturing standards.
Lipitor is a cholesterol-lowering medication in the statin class. It was created by Pfizer, and was the company’s most popular drug until the patent expired in November 2011. Since then, several pharmaceutical companies have started producing generic Lipitor, including Ranbaxy, Watson Pharmaceuticals, and Mylan. The FDA is working with Watson and Mylan to improve stocks of generic Lipitor to avert a major drug shortage.