By Zeba Siddiqui and Kanika Sikka
MUMBAI, March 8 Indian drugmaker Ranbaxy
Laboratories Ltd, reeling under a flurry of regulatory
rebukes due to manufacturing quality concerns, has recalled more
than 64,000 bottles of the generic version of a
cholesterol-lowering drug in the United States after doseage
mix-up was detected.
Ranbaxy recalled tablets of atorvastatin calcium, the
generic version of Pfizer Inc's cholesterol fighter
Lipitor, 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.
Ranbaxy, India's biggest drugmaker by revenue and majority
owned by Japan's Daiichi Sankyo Co Ltd, confirmed the
recall of select batches of the drug, but said the company had
not received any product complaints.
"Ranbaxy is proactively recalling the lots out of an
abundance of caution, keeping the safety of its patients in mind
and with the full knowledge of the U.S. FDA," the company said
in a statement issued to Reuters on Saturday.
The recall is the latest in a series of problems to hit
Ranbaxy, which has had all its India factories stopped from
sending drugs and ingredients to the United States, its biggest
Ranbaxy-owned Ohm Laboratories Inc in New Jersey is now the
company's only permitted maker of drugs for U.S. sale.
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 banned
after falling short of the FDA's "good manufacturing practices".
India's drugmakers have come under closer scrutiny as the
FDA, the guardian of the world's most important pharmaceuticals
market, has increased its presence in the country, reflecting
India's growing importance as a supplier to the United States.
Indian generic drugmakers such as Ranbaxy, Wockhardt and Dr
Reddy's Laboratories Ltd produce nearly 40 percent of
generic drugs and over-the-counter products and 10 percent of
finished dosages used in the United States.
CLASS II RECALL
The FDA declared the recall of Lipitor generic by Ranbaxy as
Class II, which signifies a remote chance of severe adverse
consequences or death due to the product flaw. This, however, is
not the first time the company has recalled the drug.
In November 2012, Ranbaxy had recalled certain lots of the
widely used cholesterol lowering medicine after it discovered
contamination with tiny glass particles.
Ranbaxy had stopped manufacturing the blockbuster drug as it
sought to fix the issues that resulted in the recall. It resumed
production for sale in the United States in February last year.
Last month, the FDA prohibited Ranbaxy from shipping to the
United States any pharmaceutical ingredient made at its Toansa
plant in northern Indian following an inspection that found poor
The ban, which followed similar actions at two plants in 2008
including Dewas and another in September 2013, has triggered
scrutiny by FDA counterparts in other countries including in
Ranbaxy shares have lost 18 percent so far this year,
compared with a 4 percent gain for the NSE Index.