Ranbaxy Pharmaceuticals Inc. has halted all production of the generic cholesterol-lowering drug Lipitor while it investigates how tiny glass particles got into dozens of batches of the drug.
The Food and Drug Administration said Ranbaxy, a subsidiary of India's Ranbaxy Laboratories Ltd, won't resume manufacturing generic Lipitor, or atorvastatin calcium, until it determines the problem's cause and fixes it.
Ranbaxy Laboratories Limited is India's largest pharmaceutical company, according to its website, and is allied with pharmaceutical Daiichi Sankyo Company Ltd. of Japan.
The problem-plagued drugmaker has been operating under increased FDA scrutiny since last December because of quality lapses at multiple factories over several years.
The November recall of atorvastatin covered 41 batches of 10-, 20- and 40-milligram doses of atorvastatin tablets.
"The Company is taking this voluntary action as a precautionary measure due to the fact that we cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size)," the company said in the FDA press release.
A full list of recalled lots can be found on the FDA's website.
A Ranbaxy spokesman did not immediately respond to messages from The Associated Press Friday.
Statins are prescribed along with diet and exercise to reduce levels of LDL (bad) cholesterol and raise levels of HDL (good) cholesterol. The drugs can slow the formation of plaque in the arteries that could lead to heart attacks and strokes.
Several other companies also make generic versions of Lipitor, which was the world's top-selling drug for years until the company's patent expired in November 2011.
Ranbaxy notified pharmacies and other customers about the recall on Nov. 9 but didn't publicly disclose it until Nov. 23 when it posted a notice on the company's U.S. website.
It covers lots, or batches, of atorvastatin in bottles containing 90 or 500 tablets. The tiny particles may be smaller than 1 millimeter in size. Patients taking these pills can contact their pharmacy to see if their pills were from affected lots.
The FDA said it has not received any reports of patients being harmed by the recalled product. The agency said its initial assessment indicates the possibility of patient harm appears to be low and any harm would be temporary.
Those with any of the recalled atorvastatin should stop taking it immediately and should ask their doctor or pharmacist about obtaining an alternative product.
Pfizer Inc.'s Lipitor and the generic versions on the U.S. market are taken by millions of patients. The FDA said it does not anticipate an atorvastatin shortage but it is working with the other manufacturers to ensure there's enough supply.
Last Friday, Ranbaxy filed a notice with the Bombay Stock Exchange stating the company'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. That no longer appears to be the case.
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.
In mid-2008, the FDA barred Ranbaxy from shipping into the U.S more than 30 different drugs made at factories in India. Meanwhile, the U.S. Department of Justice alleged the company lied about ingredients and formulations of some medications.
In early 2009, the FDA said it would not consider any new applications from Ranbaxy to sell in the U.S. any products made at the troubled factories. But last Nov. 30, on the day Lipitor's U.S. patent expired, FDA granted permission for Ranbaxy to sell a generic version made at a different factory.
A few weeks later, the FDA and the company signed an agreement called a consent decree that 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.
"Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers," Dara Corrigan, FDA associate commissioner for regulatory affairs, said in a January 25, 2012 statement.