Generic Lipitor Recall 2012: Ranbaxy Faced Justice Department Scrutiny Earlier This Year

The American subsidiary of Indian drug maker Ranbaxy Laboratories announced a recall of generic Lipitor tablets after the company discovered that batches of some of the pills may contain small glass particles.

The recall announcement by Ranbaxy comes almost a year after the U.S. Justice Department filed a consent decree against the company after the agency found issues with the firm's drug manufacturing and testing.

Ranbaxy Pharmaceuticals Inc., a subsidiary of India’s largest drug maker, Ranbaxy Laboratories Ltd, said it informed the U.S. Food and Drug Administration of the recall.

The recall of generic Lipitor includes 10mg, 20mg and 40mg tablets, the company said on its website. Ranbaxy also makes tablets in 80mg doses, which are not affected by the recall. Generic Lipitor bottles included in the recall contain either 90 or 500 pills of the cholesterol-fighting drug.

"Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for Atorvastatin calcium tablets, in connection with its 10mg, 20mg, and 40mg dosage strengths, packaged in 90’s [sic] and 500 count bottles and only with respect to certain select lot numbers,” the company announced on its website. “Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA.”

You can find a full list of generic Lipitor tablets being recalled here.

Back in January, the Justice Department said it found "numerous problems" regarding testing and drug manufacturing at Ranbaxy factories in India and the United States. Included among the issues cited by the department are failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.

The consent decree filed by the Justice Department was described as "unprecedented" at the time.

“This action against Ranbaxy is groundbreaking in its international reach -- it requires the company to make fundamental changes to its plants in both the United States and India,” said Tony West, assistant attorney general for the Justice Department's Civil Division. “Our commitment to ensuring that the drugs the American people rely on are safe, effective and manufactured according to the FDA’s standards extends beyond our borders.”

The Associated Press reported that the company was taking heat from the FDA over alleged security lapses at Ranbaxy factories, too.

The agency also claimed the drug maker lied about test results for generic drugs that were conducted several years ago, according to the AP. The tests were done to determine the shelf life of the drugs.

The FDA banned Ranbaxy from shipping 30 drugs manufactured at its Indian factories in 2008, the AP reported.

The FDA scrutiny almost led the agency not to allow Ranbaxy to sell generic Lipitor when the drug’s patent expired. But the agency ruled to allow Ranbaxy to sell generic Lipitor from the company’s New Jersey factory.