Ranbaxuy Inc. has issued a generic lipitor recall for Atorvastatin Calcium Tablets over fears that the medication may contain glass particles the size of small grains of sand.
According to the U.S. Food & Drug Administration (FDA), the generic Lipitor recall has prompted Ranbaxy to halt production of the cholesterol-lowering drug while it investigates the cause of the problems.
The generic Lipitor recall involves 41 lots of Atorvastatin Calcium Tablets in 10 mg, 20 mg and 40 mg sizes. The medication subject to the generic Lipitor recall consists of white colored pills that can be identified by the imprint RX12 on 10 mg tablets, RX828 on 20 mg tablets and RX829 on 40 mg tablets. They were packaged in in plastic bottles that contain either 90 or 500 tablets per bottle, and distributed to both retailers and wholesalers in the U.S. A complete list of lot numbers, bottle sizes and dosages of the generic Lipitor recall can be found at the FDA’s website.
So far, no adverse events have been reported in connection with the recalled Atorvastatin.
Lipitor is prescribed along with diet, exercise, and weight loss to reduce the risk of heart attack and stroke in people who have heart disease or who are at risk of developing heart disease. Brand name Lipitor is marketed by Pfizer, and was once one of its best-selling drugs. Ranbaxy, India’s largest pharmaceutical company, and the company issuing the generic Lipitor recall, was the first generic drug maker to market Atorvastatin after Pfizer’s patent expired last year. According to a report from The Wall Street Journal, Ranbaxy now holds more than 40% of the U.S. market for atorvastatin prescriptions.
According to Reuters, this is not the first time Ranbaxy has been faced with manufacturing issues. The FDA banned the company from importing some 30 medications in 2008, after finding deficiencies at two of its manufacturing plants. Ranbaxy was also accused of falsifying data used in drug applications. According to The New York Times, since January, the company has been operating under a Consent Decree with the U.S. Justice Department that prevents it from manufacturing drugs at its most troubled facilities until it can show it is meeting U.S. standards. However, the company was allowed to continue making generic Lipitor and some additional drugs at other plants.
Experts told the Times that the problems at Ranbaxy over the years highlight the disparity between the way drug manufacturers are regulated in the U.S., versus the ability of the FDA to police overseas manufacturers.
“I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education. “But my confidence is not that high when we are getting products from outside the country.”