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Generic brand of Lipitor doses recalled due to glass particles

November 23, 2012 12:00:00 AM PST
Dozens of lots of a generic version of the cholesterol drug Lipitor were recalled because some may contain tiny glass particles.

Ranbaxy Pharmaceuticals Inc. issued the recall. The Indian company has been barred by American regulators in the past due to quality lapses.

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.

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.

Patients who've filled a prescription can contact their pharmacy to determine whether it was made by Ranbaxy or another generic drugmaker and, if it's from Ranbaxy, whether it came from a recalled lot.

Ranbaxy's manufacturing deficiencies, dating to 2006, led to a lengthy investigation and sanctions by the FDA. During the probe, federal investigators found Ranbaxy didn't properly test the shelf life and other safety factors of its drugs and then lied about the results.

Ranbaxy is operating under a settlement with the FDA, called a consent decree, signed on Dec. 20, 2011. It requires Ranbaxy to improve manufacturing procedures, ensure data on its products is accurate and undergo extra oversight and review by an independent third party for five years. Ranbaxy at the time set aside $500 million to cover potential criminal and civil liability stemming from the Justice Department investigation.

A .PDF list of recalled lots is at Ranbaxy recall list.

The Associated Press contributed to this report.


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