The FDA once again issued a recall on Ranbaxy’s generic statin, this time after a pharmacist spotted a 20-mg tablet in a sealed bottle of atorvastatin calcium at 10 mg doses.
Ranbaxy Pharmaceutical has run into a host of troubles with U.S. federal agencies. In 2012, the FDA recalled lots of 10 mg, 20 mg and 40 mg dosage strengths of atorvastatin packaged in 90- and 500-count bottles because they potentially contained small glass particles. The recall prompted the drug maker to suspend production until it resolved its quality issue.
It resumed production in March 2013, the same year it paid $500 million to settle a whistleblower lawsuit that claimed it manufactured and distributed adulterated drugs at two facilities in India that were introduced into U.S. markets. Ranbaxy USA pleaded guilty to the federal charges.
The current event is a voluntary nationwide class II recall affecting 64,626 bottles of 90-count tablets of atorvastatin.