The U.S. Food and Drug Administration (FDA) have issued a nationwide recall of two batches of generic Lipitor, a cholesterol-lowering prescription medication, made by Ranbaxy Laboratories Ltd.
Ranbaxy, is pulling more than 64,000 bottles of atorvastatin calcium in the United States after a ‘product complaint’ was received by a pharmacist that he had found a 20 mg tablet in a sealed bottle marked for 10 mg tablets, according to the FDA.
This recall is on the heels of growing scrutiny on Ranbaxy after all four of their Indian facilities have been suspended from selling in the U.S. due to failure to meet the agency’s current Good Manufacturing Practices.
CLASS II RECALL
The FDA classified the recall of Lipitor as Class II, which signifies a remote chance of severe adverse consequences or death due to the product defect. This, however, is not the first time the company has recalled the drug. In November 2012 the drug maker issued a recall for possible small particles of glass.