Product News and Recalls

Maker of generic Lipitor sued

Indian company Ranbaxy Laboratories is being sued by a New Jersey man over its decision to recall a generic version of the cholesterol medication Lipitor because glass particles were found in some lots.

According to a report on Pharmalot, the recall was made only at the pharmacy level, which means consumers were not directly notified of the problem or how to respond if they became aware of it. The New Jersey plaintiff maintains Ranbaxy should have notified consumers of its decision, and is trying to force the company to provide better information as well as a refund.

A story about the lawsuit on FiercePharma notes that “Ranbaxy’s recent history with generic Lipitor has one drama after another,” including a delayed FDA approval that obliged the company to set up a backup supply deal, followed by a sales windfall and the subsequent recall.

The original Lipitor, manufactured by Pfizer Inc., has generated some drama of its own recently.

The U.S. Food and Drug Administration recently added warnings to the labels of Lipitor and other variations of the widely used anti-cholesterol drugs called statins, warning that they may increase the risk of Type II diabetes. The new labels also warn that the drugs may raise blood sugar levels, and could cause memory loss.

According to FiercePharma, Ranbaxy voluntarily recalled 41 lots of its generic Lipitor in November, and stopped production to investigate the possibility that a piece of glass broke from some machinery and was ground up during processing. At the time, the U.S. Food and Drug Administration said the risk of injury was minimal.

But lawyers for plaintiffs claiming injuries want a judge to order Ranbaxy to recall all of the generic Lipitor it distributed in the U.S.

Patients should consult their doctors before making any changes in their medication. A consultation with a Lipitor lawyer is also important if there are significant injuries.

See the Pharmalot story here:

See the FiercePharma story here: