May 26, 2003
Albers Medical Distributors Has
The Food and Drug Administration (FDA) said that Albers Medical
Distributors, Inc., has 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
As part of the FDA?s ongoing efforts to investigate and address unscrupulous
counterfeiting activities, FDA?s 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
FDA?s investigation into this matter is continuing.