Manufacturer Issues Drug Recall for Generic Lipitor for the Third Time

After learning about a dosage mix-up, India’s Ranbaxy Laboratories LTD has issued a drug recall for more than 64,000 bottles of generic Lipitor, a statin medication.

Reportedly, a pharmacist found a 20 mg tablet sealed in a bottle that should have had only 10 mg tablets. The medication is a generic version of Pfizer’s controversial cholesterol medication, Lipitor.

Ranbaxy said that they had not received any complaints of complications related to dosage problems, but they issued the recall on the FDA’s request. The company also stated that “Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the U.S. FDA.”

Several generic drug manufactures in India have come under fire in recent years because of violations of FDA regulations. Manufacturers Ranbaxy Laboratories and Wockhardt Ltd were both banned from selling prescription generic drugs in the US after federal inspectors found the companies had retested drugs’ efficacy to gain favorable results.

“Now, with the generic industry having grown up, most people are taking generic drugs,” said Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, in a telephone interview. “It’s really time to level the playing field.”

The drug recall is the latest in a series of recalls issued by the troubled drug manufacturer. In May of last year, Ranbaxy agreed to pay a record $500 million in criminal and civil fines for selling adulterated drugs, including generic Lipitor, and lying to regulators during the year-long investigation. On Monday, May 13th, Ranbaxy entered a guilty plea and agreed to pay the largest fine against a pharmaceutical company in US history, for serious violations of the Federal Food, Drug, and Cosmetics Act, which prohibits the sale of impure drugs.

Generic drugs make up 80% of the medicine used in the United States. However, generic drugs have come under fire recently because patients who suffer dangerous side effects after taking generic medications do not have the same legal recourse against generic drug manufacturers as brand name manufacturers. Generic drug makers like Ranbaxy and theirgeneric Lipitor currently cannot make changes to their labels to reflect new side effects unless the brand name drug makes the changes first.

However, the FDA is putting regulations in place to change that, so that the agency can monitor side effects of generic drugs more closely.

The Strom Law Firm Can Help with Dangerous Drug Cases, Including Against Generic Lipitor

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, like generic Lipitor, transvaginal mesh, Actos, or an all-metal hip replacement. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800