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News November 26, 2012

Glass possibility prompts Ranbaxy voluntary recall

Select packs of its generic Lipitor are pulled in the U.S.; report indicates Indian drug maker under increased FDA security.
Ranbaxy corporate

A Nov. 26  New York Daily News online story noted, “Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led U.S. regulators to bar imports of the Indian company's medicines.

“Ranbaxy, a subsidiary of Ranbaxy Laboratories Ltd., India's biggest drugmaker, is operating under increased scrutiny from the U.S. Food and Drug Administration because of quality lapses at multiple Ranbaxy factories over the past several years. The FDA also has alleged the company lied about test results for more than two dozen of its generic drugs several years ago.”

India’s Ranbaxy (whose corporate office is shown here) announced in late November, “It is conducting a voluntary recall only in the U.S. healthcare system for select batches and strengths of Atorvastatin calcium tablets. The recall is in connection with its 10-, 20- 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 or any other Ranbaxy Product in any other market.

“The recall is being conducted in the U.S. at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1 mm 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. This recall is being conducted with the full knowledge of the U.S. FDA. The recall is limited to the U.S. market only and affects specific lots numbers and strengths of this molecule manufactured by Ranbaxy only for sale in the U.S.

“Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US is not affected in any way by this recall. The activities taking place in the U.S. will not affect Ranbaxy's ability to continue to supply product in any other markets.”


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