A New Jersey drug company is recalling more than 140,000 bottles of a prescribed cholesterol drug that it found did not meet the required standards.

Ascend Laboratories says it is recalling Atorvastatin calcium tablets in 10, 20,40 and 80 milligram dosages. This product is the generic version of the popular and much-prescribed drug Lipitor.

The recall affects bottles with 90, 500 and 1,000 tablets and expiration dates as far ahead as February 2027. The initial recall came Sept. 19.

Atorvastatin, the generic version of the popular Lipitor cholesterol drug, works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

During an investigation of Atorvastatin, out-of-specification results for dissolution testing were confirmed for thirty batches.

Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

The primary hazard associated with the affected batches is therapeutic failure or reduced efficacy.

Because the tablets fail to meet the dissolution specification, patients would not receive the intended dose of the medication within the stipulated time. However, no adverse events have been reported to our firm to date.

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