Beware of counterfeit atorvastatin calcium

The U.S. Food and Drug Administration (FDA) is warning pharmacists and consumers to beware of counterfeit atorvastatin calcium (Lipitor).

The FDA originally issued its alert on the counterfeit cholesterol-lowering drug on May 23, when the agency’s investigation turned up three lots of 90-count bottles. The agency announced that Albers Medical Distributors of Kansas City, MO, was voluntarily recalling 100,000 bottles. On June 3, the FDA announced the discovery of three additional lots (30,000 bottles) of the counterfeit drug.

The counterfeit product labels say "Repackaged by: MED-PRO, Inc. Lexington, Neb." in the lower left-hand corner. Pharmacists also should look for these lot numbers and notify consumers if they might have received the counterfeit drug:

  • 20722V — 90-tablet bottles, 10 mg, expiration 09-2004
  •  04132V — 90-tablet bottles, 10 mg, expiration 01-2004
  • 16942V — 90-tablet bottles, 10 mg, expiration 09-2004
  • 20842V — 90-tablet bottles, 10 mg, expiration 09-2004
  • 16092V — 90-tablet bottles, 10 mg, expiration 07-2004
  • D270481 — 90-tablet bottles, 20 mg, expiration not available

Pfizer, the manufacturer of atorvastatin, announced June 3 that it was suing Med-Pro and Albers to ensure they immediately stop the distribution of the counterfeit atorvastatin. Pfizer says it does not distribute the drug to Med-Pro and has no relationship with the company or with Albers Medical Distributors. Albers and Med-Pro deny involvement in the counterfeiting of atorvastatin.

According to Pfizer’s analysis, tablets from Med-Pro packages purporting to contain Lipitor 10 mg and 20 mg bear a close resemblance to the authentic drug, though they may be slightly thicker. Consumers have reported that the counterfeit tablets dissolve more quickly and have a bitter taste.