March 7 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
Ranbaxy could not be reached for comment outside of India's
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".