June 4, 2003
Recall Update: Additional Counterfeit
The Food and Drug Administration (FDA) said that it is continuing an
investigation of counterfeit Lipitor and has turned up additional counterfeit
quantities of the cholesterol-lowering pharmaceutical product. Two
additional lots of 10 mg tablets in 90-tablet bottles, coded 20842V and
16092V, and one lot of 20 mg tablets in 90-tablet bottles, coded D270481,
are involved. The labeling on each of these bottles states, ?Repackaged by:
MED-PRO, INC., Lexington, NE 68850.?
Since learning of problems with this product late last month, FDA
investigators have aggressively pursued a variety of leads all along the
supply and distribution chain. Evidence of the new lots of implicated
Lipitor arose in the context of FDA?s investigation.
FDA?s advice to healthcare providers and consumers remains the same as when
the agency issued its original alert on counterfeit Lipitor May 23, 2003.
They should check the packaging very carefully before using Lipitor.
Patients who have any of the product (labeled as ?Repackaged by: MED-PRO,
INC. Lexington, NE 68850?) with any of the following lot numbers should not
take it, and they should return the product to their pharmacies:
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.
FDA is working closely with the individual states and with health
professionals, especially with pharmacists and pharmacy associations, to
alert them to this counterfeit product. Many patients taking Lipitor do not
receive it in the 90-tablet bottles being recalled, but in smaller
quantities from their pharmacists. Patients who are not sure whether they
have the implicated product should check with their pharmacist.
FDA is also working closely with the manufacturer of Lipitor, Pfizer, Inc.,
on this counterfeiting problem. FDA supports the activities of legitimate
manufacturers to inform the public about counterfeit products and how to
identify them. Last month, FDA entered into an agreement with a major
pharmaceutical trade association to cooperate more closely on cases of
suspected counterfeit products.
FDA?s investigation into this matter is continuing.