FDA issues Class II warning for generic version of popular cholesterol drug

An estimated 141,984 bottles of a popular cholesterol medication have been recalled because they may not meet certain regulations. New Jersey-based Ascend Laboratories, LLC issued the recall last month and updated it this month with the Food and Drug Administration.

Although the recall was first initiated on Sept. 19, the FDA did not issue a press release to the public alerting them of the matter.

The recall applies to 10mg, 20mg, 40mg and 80mg bottles of atorvastatin calcium tablets manufactured by Alkem Laboratories, Ltd., of India, and sold by Ascend. Atorvastatin calcium is most commonly known as Lipitor and is a type of statin drug used to lower cholesterol.

“Statins block an enzyme the liver needs to make cholesterol. This causes the liver to remove cholesterol from the blood,” according to the Mayo Clinic. “While statins are effective and safe for most people, they have been linked to muscle pain, digestive problems, and mental fuzziness in some people. Rarely, they may cause liver damage.”

Statins are used by more than 200 million people worldwide, according to John Hopkins Medicine.

The recall is necessary as Ascend determined its pills may not dissolve or release their active ingredients as required by industry standards.

The FDA designated the recall as a Class II, the middle risk level for the agency’s three-tier system.

A Class II recall is considered “A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The FDA did not provide any guidance for individuals who may have the recalled pills in their possession.