Shocking dosage mix-up forces Ranbaxy to recall generic Liptor in US

Troubled Indian drug maker Ranbaxy Laboratories has received a further setback in its main market, the United States, as it has been forced to recall generic version of the cholesterol-lowering drug Lipitor in the US because of potential dosage mix-ups due to shoddy bottling.

Ranbaxy has already been banned from exporting drugs made at any of its four Indian plants to the US because of the federal drug agency Food and Drug Administration's (FDA) concerns about quality. Now, it has recalled over 64,000 bottles of 10-milligram tablets of atorvastatin calcium - the active ingredient in Lipitor - saying some bottles could possibly contain a higher dose, the FDA said in a note.

Ranbaxy confirmed the recall on Friday, noting that the process started in mid-January. Notice of the recall was posted on the FDA's website this week.

The company makes ingredients for drugs used in oncology, dermatology, gastrointestinal and cardiovascular disorders. It saw 36 per cent of its revenue from the US in the quarter ended in December, despite various strictures on its drugs.

The suspension of shipments to the US has affected supplies to other key markets such as Europe and India.

Ranbaxy recalled its atorvastatin calcium tablets after a pharmacist found a 20-mg tablet in a sealed bottle marked for 10-mg tablets, the FDA said. The US drug regulator declared a Class II recall, which signifies a remote chance of severe adverse consequences or death due to the product flaw.

This is at least the third recall by Ranbaxy of its generic versions of Lipitor over the past two years. India's biggest drug maker by revenue had recalled 480,000 bottles of the cholesterol buster in November 2012 after the company discovered contamination with tiny glass particles. (See: Ranbaxy recalls generic Lipitor in US market over glass particles in bottles)

Ranbaxy has recently been targeted by the FDA over its manufacturing practices and quality controls at several plants in India and the US.

 It has also been hauled up by the FDA for falsifying data and test results in approved and pending drug applications, which could lead to defective products.

Late last week, Ranbaxy suspended all shipments of pharmaceutical ingredients produced at its Toansa and Dewas factories to review processes and controls after the FDA prohibited the company from shipping drugs manufactured from these plants to the US. (See: Ranbaxy suspends all shipments from Toansa, Dewas plants)

This is the fourth unit of Ranbaxy to be proscribed by the FDA – and it means that all of the company's Indian plants have been banned by the FDA. Its other units at Paonta Sahib in Himachal Pradesh and Mohali in Punjab have already been banned from supplying any products to the US.

In May 2013, Ranbaxy was also slapped with a record $500 million fine to settle a US civil and criminal lawsuit for selling adulterated drugs and falsifying data.

Ranbaxy, India's largest pharmaceutical company, was the first to market the generic version of Lipitor in late 2011 after Pfizer lost its US patent protection on 30 November 2011.

The Gurgaon-based company was given rights to 180 days of marketing exclusivity by the FDA for being the first to file for a generic equivalent.

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".