Ranbaxy Laboratories, reeling under a flurry of regulatory rebukes because of poor quality, has recalled more than 64,000 bottles of the generic version of a cholesterol-lowering drug in the US after doseage mix-up was detected.
Ranbaxy recalled tablets of atorvastatin calcium, the generic version of Pfizer’s cholesterol fighter Lipitor, after a pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, the US Food and Drug Administration (FDA) said on its website.
Ranbaxy, the country’s biggest drug maker by revenue and majority owned by Japan’s Daiichi Sankyo, 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 US FDA,” the company said in a statement.
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 US, its biggest market.
Ranbaxy-owned Ohm Laboratories Inc in New Jersey is now the company’s only permitted maker of drugs for US 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 have been banned after falling short of the FDA’s “good manufacturing practices”.
Domestic drug makers have come under closer scrutiny as the FDA has increased its presence in the country, reflecting India’s growing importance as a supplier to the US.
Indian generic drug makers such as Ranbaxy, Wockhardt and Dr Reddy’s Laboratories produce nearly 40 per cent of generic drugs and over-the-counter products and 10 per cent of finished dosages used in the United States.
Class II act
The FDA declared the recall of Lipitor generic by Ranbaxy as Class II, which signifies a remote chance of severe adverse consequences or death because of 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.