Ranbaxy Laboratories has stopped production of its generic version of cholesterol lowering drug Lipitor until it investigates the issue of potential glass particles in certain lots, the U.S. health regulator has said.
The Indian drug major, on November 9, had informed its customers of a voluntary recall of certain lots of the company’s 10mg, 20mg, and 40mg dosage strengths of atorvastatin tablets (generic version of Lipitor), the U.S. Food and Drug Administration (USFDA) said in a statement.
The lots of atorvastatin packaged in bottles of 90 tablets and 500 tablets are being recalled due to possible contamination with very small glass particles similar to the size of a grain of sand (less than 1 mm in size), the statement added.
Based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility of adverse events related to the recalled product appear to be low, and if any adverse events are experienced, they would be temporary, the U.S. health regulator noted.
The agency will continue to oversee the recall process, and work with Ranbaxy to resolve these pharmaceutical quality issues, it added.