Recall of Lipitor Generic Equivalent Issued Due to Wrong Doses

Ranbaxy has recalled more than 64,000 bottles of generic Lipitor, after it was discovered that some pills with the wrong dose of the cholesterol drug may be in some of the bottles.  

The generic Lipitor recall was announced by the FDA last week, after the company sent a letter to pharmacists in January indicating that at least one pill with the incorrect dose was found.

According to the FDA, a pharmacist reported finding a tablet of 20 mg atorvastatin inside a 90-count bottle of 10 mg atorvastatin tablets. No illnesses or adverse events have been reported in connection with the generic Lipitor recall.

The recall affects 64,626 bottles of Atorvastatin Calcium Tablets, 10 mg, sold in 90-count bottles by Ranbaxy Pharmaceuticals Inc. with lot numbers 2407255 and 2407256 and an expiration date of 05/14, and an NDC number of 63304-827-90.

The letter sent out by Ranbaxy indicates that this latest recall is related to an earlier recall issued in August 2012. This is an expansion of that recall after the company’s investigation revealed that two more lots may have been affected. The recalled lots impact bottles distributed in 2012.

The FDA has given the recall a Class II designation, meaning that it believes the risk of injury is remote or that such injuries would be reversible.

Ranbaxy Generic Lipitor Problems

Lipitor (atorvastatin) was first approved by the FDA in December 1996 for use in lowering cholesterol. It is a member of a class of drugs called statins and works by inhibiting an enzyme in the liver that takes part in cholesterol production.

Pfizer manufactures the name brand version of Lipitor, but the patent expired in November 2011. In addition to Ranbaxy, generic versions of Lipitor are also manufactured by Mylan and Watson Pharmaceuticals.

This is the largest Ranbaxy recall for their Lipitor generic equivalent since November 2012, when the company recalled 41 lots due to the risk of glass particle contamination. Ranbaxy has only been allowed to sell generic Lipitor in the United States, after the FDA banned about 30 of its drugs from the market in this country amid a number of manufacturing problems

The generic drug maker has also been accused of faking data sent to the FDA. The agency and Ranbaxy reached a consent decree in January 2012, which required the company to rehabilitate its manufacturing processes until they meet FDA standards.In 2013, Ranbaxy agreed to pay $500 million for making false statements to the FDA.

Lipitor Litigation

The recall comes as Pfizer faces hundreds of Lipitor lawsuits filed by women throughout the United States, who allege they developed diabetes after using the cholesterol drug.

In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add new warnings about the potential impact of the medication on blood glucose levels. However, many critics have suggested that the warnings are not strong enough for certain medications, indicating that users and the medical community should be provided with more accurate information about the diabetes risks from Lipitor, Crestor and other statins.

Plaintiffs allege that use of the medication as a preventative measure to prevent heart failure has caused them to develop diabetes, which carries a number of health risks, including an increased risk of heart disease. Plaintiffs claim that the drug maker knew or should have known about Lipitor diabetes problems for years, but withheld information to avoid a negative impact on sales and growth of the blockbuster medication.