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Company Recalls Generic Lipitor Over Safety Concerns

Filed November 26th, 2012 Laurie

The manufacturer of generic Lipitor is recalling 10-, 20-, and 40-milligram tablets of the cholesterol-reducing medication due to concerns that they may contain small particles of glass.

Ranbaxy Pharmaceuticals Inc. said 41 lots of 90- and 500-count bottles that are subject to recall. That action was taken “with the full knowledge” of the U.S. Food and Drug Administration (FDA), which first approved the drug in 2011. The FDA harshly criticized the company in 2006 and 2008 over conditions at two of its plants in India. After it was discovered that Ranbaxy had submitted false data to the FDA, the firm entered into an agreement with the U.S. Justice Department in January 2012 barring it from manufacturing products for the American market at either of the plants until they could meet U.S. standards, according to CNN.

Ranbaxy’s U.S. subsidiary issued a statement that read, “The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind,” CNN reported.

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