The FDA is urging health care providers and people who take the cholesterol-lowering drug Lipitor (atorvastatin) to examine labels on the drug carefully following reports of counterfeit versions of the drug.
In May, Albers Medical Distributors Inc. recalled three lots of 90-count bottles of Lipitor. The company warned that these lots represent a potentially significant risk to consumers. The product was repackaged by Med-Pro Inc. of Lexington, Neb.
The lots in that recall were:
* 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
The labels say "Repackaged by: MED-PRO Inc., Lexington, Neb." in the lower left corner.
In June, the FDA announced that its investigation had uncovered additional counterfeit Lipitor:
* 29842V--90-tablet bottles, 10 mg, Expiration 9-2004
* 16092V--90-tablet bottles, 10 mg, Expiration 7-2004
* D270481--90-tablet bottles, 20 mg, Expiration not available The labeling on each of these bottles states, "Repackaged by: MED-PRO, INC., Lexington, NE 68850."
Anyone who has Lipitor with these lot numbers should not take it and should return the product to the pharmacy where it was purchased. Many people who take Lipitor do not receive it in the 90-tablet bottles being recalled, but in smaller quantities from their pharmacists. People taking Lipitor who have questions about their product should check with their pharmacists. The FDA is working closely with Pfizer Inc., the manufacturer of Lipitor, as well as with health professionals on this counterfeit problem.
In carrying out its public health mission, the FDA regularly conducts investigations and testing to identify and remove products from the market that are counterfeit, have been tampered with, or are otherwise unsuitable. The FDA's Office of Criminal Investigations (OCI) continues to investigate the matter.
In April, the Pharmaceutical Research and Manufacturers of America, a trade association representing pharmaceutical and biotechnology companies, announced that its members would notify the FDA of suspected counterfeit cases within five working days as part of a voluntary program to combat the practice.
COPYRIGHT 2003 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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