Drug recalled over glass concerns
Ranbaxy Pharmaceuticals Inc. says it is calling back bottles of its 10-, 20- and 40-milligram tablets of atorvastatin calcium, the generic version of the widely prescribed anti-cholesterol drug Lipitor. A total of 41 lots of 90- and 500-count bottles are subject to the recall, the company said.
“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’s U.S. subsidiary said in a statement on its website. “Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind.”
Ranbaxy said its action was taken “with the full knowledge” of the U.S. Food and Drug Administration, which granted the company its approval to manufacture the drug at a plant in New Jersey in 2011.
India-based Ranbaxy came under fire from FDA officials over conditions at two Indian plants in 2006 and 2008. That led to a January 2012 agreement with the Justice Department that cited the company for submitting false data to the FDA and barred the company from manufacturing drugs for the American market at those facilities until they could meet U.S. standards.