Glass particles force recall of Ranbaxy Lipitor
pharmafile | November 27, 2012 | News story | Manufacturing and Production, Sales and Marketing | Daiichi Sankyo, Lipitor, Pfizer, Ranbaxy, recall
Ranbaxy Pharmaceuticals is recalling around 40 batches of its generic atorvastatin tablets after discovering that some of the product may be contaminated with glass particles.
The recall includes thousands of 90- and 500-count bottles of the cholesterol-lowering drug in doses of 10mg, 20mg and 40mg, and is being undertaken “out of an abundance of caution” according to the Indian firm, which is a subsidiary of Japan’s Daiichi Sankyo.
The FDA has suggested the move may lead to a shortage of generic atorvastatin, which is also sold in the US by Mylan and Watson Pharmaceuticals amongst other firms. The drug was originated by Pfizer, which sells it as Lipitor.
The news comes as Ranbaxy has just started to break free of manufacturing quality problems that have dogged the company since 2008, when the FDA put an import ban on products manufactured at three Indian facilities.
The plants remain under a five-year FDA consent decree signed earlier this year, and Ranbaxy has also pledged to upgrade systems at other facilities while setting aside $500 million to meet any criminal or civil liabilities associated with its manufacturing problems.
Ranbaxy was cleared to start selling atorvastatin made at its US facility Ohm Laboratories towards the end of 2011, and started supplying the US market from a plant in Mohali, India, once the import ban for that product was lifted in April 2012. Imports of some other Ranbaxy products remain prohibited.
Analysts said the recall could have a material impact on Ranbaxy’s finances, given that generic atorvastatin has been a huge earner for the company and it had market exclusivity for six months after the Lipitor patent expired.
The product added $600m to Ranbaxy’s revenues in the first half of the year, and even though it no longer has exclusivity the company says it continues to be the biggest-selling generic atorvastatin in the US.
Ranbaxy said it was investigating the root cause of the glass contamination and hoped to start resuming shipments within a couple of weeks.
Phil Taylor
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