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6/18/2003

Recall of Counterfeit Lipitor Expanded

Donna Young

The Food and Drug Administration (FDA) yesterday announced that Albers Medical Distributors Inc. of Kansas City, Mo., has expanded its recall of counterfeit atorvastatin calcium, or Lipitor, to include all atorvastatin products repackaged by Med-Pro Inc. of Lexington, Neb.

Smith Wholesale Drug Co. of Springfield, Ill., has also recalled Lipitor products repackaged by Med-Pro.

FDA issued an alert on May 23 that Albers Medical was voluntarily recalling three lots of Lipitor after discovering the counterfeit product. The agency issued a second alert on June 3 warning consumers, pharmacists, and health care providers that three more counterfeit lots had been identified.

As of yesterday, FDA's forensic chemistry center in Cincinnati, Ohio, had not identified "any known harmful substances in the counterfeit tablets," according to an agency statement.

Testing showed that the tablets contained atorvastatin, but FDA said it "cannot assure that the counterfeit products are safe and effective."

Pfizer, the company that markets Lipitor, issued a statement on June 3 stating that it does not distribute the product to Med-Pro and has no relationship with the company or with Albers Medical.

In the statement, Pfizer said that it was made aware of the counterfeit Lipitor when patients and pharmacists complained that the drug had an unusually bitter taste.

Pfizer said it has initiated legal proceedings against Med-Pro and Albers "that seek to immediately stop the distribution of counterfeit Lipitor."

Patients and health care providers should inspect Lipitor packaging very carefully before using the product, FDA said. The agency advised patients to return to their pharmacies any Lipitor labeled as "Repackaged by: MED-PRO Inc.; Lexington, NE 68850."