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5/27/2003

Repackager Recalls Counterfeit Lipitor

Donna Young

The Food and Drug Administration (FDA) issued a warning on Friday alerting pharmacies, consumers, and health care providers about counterfeit atorvastatin calcium, a cholesterol-lowering drug sold under Pfizer’s brand name Lipitor.

Albers Medical Distributors Inc. of Kansas City, Mo., has voluntarily recalled three lots of 90-table bottles bearing lot numbers 04132V, with an expiration date of January 2004; and lots 20722V and 16942V, expiring September 2004.

The product, according to FDA, was repackaged by Med-Pro Inc. of Lexington, Neb

The agency is urging health care providers and consumers to inspect Lipitor packaging carefully before using the product.

FDA is counseling patients to return to their pharmacy all bottles of the product with labels bearing "Repackaged by Med-Pro Inc." in the lower-left-hand corner and any of the three lot numbers identified as counterfeit.

The agency issued a warning letter in April 2000 to Med-Pro about deficiencies at the company’s facility that could "cause human drugs being repacked at this facility to be adulterated."

At least five FDA enforcement reports issued between July 1997 and September 2000 listed recall notices for products repackaged by Med-Pro. 

FDA’s Office of Criminal Investigations is investigating the counterfeit Lipitor.