MUMBAI: Ranbaxy Laboratories, facing a host of regulatory issues, has recalled over 64,000 bottles of the generic version of a cholesterol-lowering drug, Lipitor, in the US after a dosage mix-up was detected. It recalled the tablets of atorvastatin calcium after a pharmacist found a 20mg tablet in a sealed bottle marked for 10mg tablets, the US Food and Drug Administration said on its website.
Ranbaxy, India’s biggest drugmaker by revenue and majority owned by Japan’s Daiichi Sankyo, confirmed the recall of select batches of the drug. But it said the company had not received any product complaints. The recall is being conducted at the retail level. A company spokesperson said 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 recall is the latest in a series of problems to hit Ranbaxy, which has had all its domestic units banned from sending drugs and ingredients to the US, its biggest market.
In November 2012, Ranbaxy had recalled certain lots of the widely used cholesterol-lowering medicine after it discovered contamination with tiny glass particles. Later in January 2014, Ranbaxy announced it is conducting a voluntary recall in the US limited to two lots of atorvastatin calcium tablets, 10mg, manufactured in India, which expire in May 2014. After the first recall in November 2012, Ranbaxy had stopped manufacturing the drug as it sought to fix the issues that resulted in the recall. It resumed production in February last year.
In the recent regulatory action against the company, the FDA banned Ranbaxy from shipping to the US any pharmaceutical ingredient made at its Toansa plant in Punjab following an inspection that found poor manufacturing practices.