Risk Of Glass Particles In Generic Lipitor Prompts FDA Recall
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(CBSNews) – Ranbaxy Pharmaceuticals Inc. is recalling more than 40 lots of atorvastatin pills — the generic version of the popular statin Lipitor — over possible glass contamination.
Statins, or lipid-lowering drugs, are among the most commonly prescribed medications in the United States. The drug Lipitor was hugely popular for Pfizer until the company’s patent expired in November 2011.
A generic version of the drug is now being recalled by the India-based Ranbaxy because small glass particles approximately less than 1 millimeter in size may be in select batches, the company said on its U.S. website.
The company’s voluntary recall affects certain lot numbers of 10 milligram, 20 milligram and 40 milligram dosage strengths of atorvastatin calcium pills that are packaged in 90- and 500-count bottles. Ranbaxy said the recall is being conducted with knowledge of the U.S. Food and Drug Administration.
A complete list of lot numbers, bottle sizes and dosages can be found on Ranbaxy’s website. Patients taking these pills can contact their pharmacy to see if their pills were from affected lots.
Atorvastatin is prescribed along with diet, exercise, and weight loss to reduce the risk of heart attack and stroke and other cardiovascular ailments in people who have heart disease or who are at risk of developing heart disease.
Ranbaxy Laboratories Limited is India’s largest pharmaceutical company, according to its website, and is allied with pharmaceutical Daiichi Sankyo Company Ltd. of Japan.
Reuters reports the company was the first to launch generic Lipitor in the U.S. once Pfizer’s patent expired.
“The development will impact the company’s credibility to an extent,” Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh, told Reuters. “There have been issues in the past (about compliance) and a recall suggests, corrective measures suggested by the U.S. FDA are not being implemented.”
Earlier this year, the FDA and Ranbaxy settled an ongoing legal battle over questionable manufacturing practices and “data integrity issues” at several of the company’s Indian facilities and one located in New York State. A consent decree was filed by the U.S. Department of Justice on behalf of the FDA in which the drug manufacturer agreed to remedy these problems.
“Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers,” Dara Corrigan, FDA associate commissioner for regulatory affairs, said in a January 25, 2012 statement. “The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market.”
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