Ranbaxy Pharmaceuticals has halted productions of its generic version of the cholesterol drug Lipitor after recalling a second batch of tablets in the 10mg, 20mg, and 40mg dosage strengths.
The lots of atorvastatin (the chemical name) are packaged in bottles of 90 and 500 tablets, and 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),” according to the U.S. Food and Drug Administration.
Ranbaxy, which is among the biggest sellers of generic Lipitor, is based in India but has its U.S. headquarters in Princeton.
The FDA said it is working with other manufacturers of atorvastatin to ensure adequate supplies and avoid a shortage.
The company said it had no reports of patients experiencing adverse effects, but it could not rule out the possibility.
Ranbaxy has had previous productions problems. The Justice Department got involved and the company is working under a consent decree .
"Americans expect and deserve safe, effective, and high quality medications," the FDA said in its statement on the Ranbaxy recall. "The FDA continues to evaluate information associated with this recall and will notify the public as new information becomes available. The agency will continue to oversee the recall process, and work with the Ranbaxy to resolve these pharmaceutical quality issues."