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May 23, 2003
FDA Alerts Consumers and Health Professionals
to Recall of Counterfeit Lipitor
The Food and Drug Administration (FDA) today
announced that Albers Medical Distributors, Inc., has voluntarily
recalled three lots of 90-count bottles of the cholesterol-lowering
drug Lipitor and is warning healthcare providers and others that these
three lots of counterfeit Lipitor represent a potentially significant
risk to consumers. The product was repackaged by Med-Pro, Inc., of
Lexington, Neb., and the labels say "Repackaged by: MED-PRO, Inc.
Lexington, Neb." in the lower left-hand corner.
The following lots are involved in this recall:
- 20722V - 90-tablet bottles, Expiration 09-2004
- 04132V - 90-tablet bottles, Expiration 01-2004
- 16942V - 90-tablet bottles, Expiration 09-2004
FDA is urging healthcare providers and patients alike to check the
packaging very carefully before using this product. Patients who have
any of the product (labeled as "Repackaged by MED-PRO, Inc.") with
these three lot numbers should not take it, and they should return the
product to their pharmacies.
As part of the FDAs ongoing efforts to investigate and address
unscrupulous counterfeiting activities, FDAs Office of Criminal
Investigations is investigating the existence of counterfeit Lipitor.
Lipitor is a member of a class of cholesterol-lowering drugs that are
commonly referred to as "statins."
In carrying out its public health mission, FDA regularly conducts
investigations and testing to identify and remove from market products
that are counterfeit, have been tampered with, or are otherwise
unsuitable.
FDA supports the activities of legitimate manufacturers, in
cooperation with FDA, to inform the public about counterfeit products
and how to identify them. The agency is committed to rooting out
counterfeiting activity and alerting the public to the existence of
counterfeit product. Earlier this month, FDA entered into an agreement
with a major pharmaceutical trade association to cooperate more
closely on cases of suspected counterfeit products.
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