The U.S. Food and Drug Administration said on its website that Indian generic drugmaker Ranbaxy Laboratories will stop manufacturing its version of Pfizer Inc.’s cholesterol fighting drug, Lipitor, while it gets to the bottom of the cause of a recent recall.
Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the company discovered contamination with tiny glass particles.
The company is conducting an investigation which it expects will take two weeks. It did not report any injuries connected to the tainted pills and did not say how the problem was discovered. The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny following a long-running dispute with the U.S. Food and Drug Administration.
Last December, Ranbaxy agreed to make changes to its manufacturing plants in the United States and India. And it said it would set aside $500 million to resolve any potential civil or criminal charges stemming from an investigation by the U.S. Department of Justice. A recall suggests corrective measures suggested by the U.S. FDA are not being implemented.
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