Dozens of lots of the generic version of the cholesterol drug Lipitor has been recalled by Ranbaxy Pharmaceuticals Inc. because some may contain tiny glass particles, Associated Press is reporting.
“Ranbaxy, a subsidiary of Ranbaxy Laboratories Ltd., India’s biggest drugmaker, is operating under increased scrutiny from the U.S. Food and Drug Administration because of quality lapses at multiple Ranbaxy factories over the past several years. The FDA also has alleged the company lied about test results for more than two dozen of its generic drugs several years ago,” says the AP report.
“On Friday, Ranbaxy posted a notice on its U.S. website, saying it’s recalling 10-, 20- and 40-milligram doses of tablets of atorvastatin calcium. That’s generic Lipitor, the cholesterol fighter that reigned for years as the world’s top-selling drug. The recall includes 41 lots of the drug, nearly all with 90 pills per bottle, but three lots contain 500 pills per bottle. It’s unclear how many bottles are in each lot, but medicine batches typically contain many thousands of pills. The 80-milligram strength tablets are not affected.”
Other brands of generic Lipitor are not being recalled.
However, Reuters says the recall could result in some shortages.
“The recall could cause shortages of the drug in the United States, analysts said. Ranbaxy, the first company to introduce generic Lipitor after Pfizer’s patent expired in November 2011, controls about 60 percent of the market, according Ross Muken, an analyst at ISI Group LLC.”
“Given its dominant share of this high-volume drug, we are certain to see supply shortages over the next two weeks,” Muken said. The near-term impact is likely to be felt most by retail pharmacies and more modestly by wholesalers, he added.
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