TRENTON, N.J. (AP) — Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led U.S. regulators to bar imports of the Indian company's medicines.
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.
Ranbaxy spokesman Chuck Caprariello did not answer questions or provide any additional information beyond the statement on the company's website.
"Ranbaxy is proactively recalling the drug product lots out of an abundance of caution," the website statement read. "This recall is being conducted with the full knowledge of the U.S. FDA."
The company also filed a two-sentence statement with the Bombay Stock Exchange stating Ranbaxy's investigation would be completed within two weeks, but that after that temporary disruption to the U.S. supply, the company expected to resume shipments here.
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.