Generic Cholesterol Drug Recalled for Presence of Glass Particles

Dozens of batches of a generic form of the drug Lipitor have been recalled, after tiny bits of glass were discovered. The drug is manufactured by an Indian firm with a history of quality-control issues.

Our defective drug attorneys understand that the company, Ranbaxy Pharmaceuticals Inc., is that country’s largest. It wasn’t long ago that U.S. regulators banned imports of the company’s medicine amid quality-control concerns. Over the last several years, the U.S. Food and Drug Administration has cited the company for numerous lapses in quality. And company officials reportedly lied to authorities about test results on more than 24 of its generic drugs.

Back in 2006, the company underwent an extensive investigation and was sanctioned by the FDA for failing to properly test the safety and shelf life of its products; it was also accused of blatantly lying about those results to federal investigators.

Two years later, the FDA banned Ranbaxy shipments of more than 30 different medicines, while the U.S. Department of Justice ordered the company to hand over internal documents that allegedly proved it was dishonest about the formulations and ingredients used in certain medicines.

But because Ranbaxy held the only license to legally produce the generic form of Lipitor just after the patent expired (and only one company can compete with the brand name for at least the first six months), the FDA agreed to lift the ban, so long as the medicines were made at the firm’s New Jersey laboratory.

Lipitor is the world’s top-selling drug. The generic version, called atorvastatin, is also a blockbuster with Ranbaxy being a top producer. On the company’s U.S. website recently, the firm recalled 10, 20 and 40-milligram doses of the pills. In all, there are more than 40 lots of the drug that have been deemed to be potentially hazardous. Each of those bottles contains about 90 pills, though there are a handful of lots in which the pill bottles contain 500. We don’t know how many bottles specifically were in each of these lots, but when it comes to batches of medicine, most tend to contain several thousand pills each.

Company executives have refused to answer questions or provide any additional answers about the recall, other than a terse, written statement stating that the recall is only being done out of an abundance of caution.

Those who have a prescription of the drug should immediately stop taking it and contact their pharmacy to determine whether their pills were made by this particular drug maker and whether their pills were among the lots affected by the recall.

This case is the latest in a string of safety and health concerns regarding prescription drugs. A Massachusetts company, the New England Compounding Center, has come under fire for contamination concerns after steroid injections distributed nationwide caused numerous fungal meningitis deaths and illnesses. NECC’s sister company, Ameridose, has also fallen under intense scrutiny for cleanliness concerns and is one of the largest suppliers of pre-filled syringes to hospitals and clinics nationwide.

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Additional Resources:
Recall: Generic Lipitor Doses, Nov. 24, 2012, Staff Report, Associated Press

More Blog Entries:
J&J & The Risk of Recalled Medical Products, Oct. 4, 2012, Product Liability Lawyer Blog