Cholesterol-lowering generic Lipitor recalled for glass particles
By NBC News services
Indian drugmaker Ranbaxy Laboratories Ltd has recalled its generic version of Pfizer Inc.'s cholesterol-lowering drug Lipitor in the United States after certain batches were found to contain glass particles.
Ranbaxy's U.S. subsidiary, Ranbaxy Pharmaceuticals Inc, said the recall affects certain lots of 10-, 20- and 40-milligram doses of the drug, known generically as atorvastatin calcium. The 80-milligram dosage is not affected.
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.
It's the latest in a series of problems, dating to 2006, involving manufacturing deficiencies at multiple Ranbaxy factories and alleged doctoring of test results on some medicines. U.S. regulators had banned imports of 30 Ranbaxy medicines and wouldn't approve any new products for sale until Ranbaxy agreed to make improvements and be monitored by a third party for five years.
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"Given its dominant share of this high-volume drug, we are certain to see supply shortages over the next two weeks," said Ross Muken, an analyst at ISI Group LLC. The near-term impact is likely to be felt most by retail pharmacies and more modestly by wholesalers, he added.
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. |
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