Indian drug maker Ranbaxy Laboratories Ltd has recalled more than 64,000 bottles of the generic versions of its cholesterol-lowering drug in the United States due to reports of a dose mix-up, U.S. regulators said.
Ranbaxy recalled tablets of atorvastatin calcium, the generic name for Lipitor’s active ingredient, after a pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, the U.S. Food and Drug Administration (FDA) said on its website.
The FDA declared a Class II recall, which signifies a remote chance of severe adverse consequences or death due to the product flaw.
Ranbaxy could not be reached for comment outside of India’s business hours.
This is at least the third recall of generic Lipitor over the past two years.
Hit by regulatory scrutiny, India’s biggest drug maker by revenue had recalled 480,000 bottles of the cholesterol fighter in November 2012 after the company discovered contamination with tiny glass particles.
Worries about quality control in India’s $14 billion drug industry have come to the fore in the past year as plants run by Ranbaxy and local rival Wockhardt Ltd have been barred from sending drugs to the United States after falling short of the FDA’s “good manufacturing practices”.
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