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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-51
July 29, 2005

Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Alerts U.S. Residents to Recall of Counterfeit "Lipitor" Sold in the United Kingdom

The Food and Drug Administration (FDA) is alerting U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.). The medicine is used to treat high cholesterol. The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28, 2005.  Health authorities in the U.K. stated that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients, however, they are advising that patients stop taking the drug and return it to the pharmacy where they obtained it.  U.K. pharmacies are being advised to return all remaining stock of this batch to Pfizer Ltd., the manufacturer of Lipitor.  

Consumers who purchased FDA-approved Lipitor products through legitimate U.S. pharmacies should not have received any of these counterfeit tablets and are not subject to this recall. But some U.S. residents may have obtained prescription drugs from the U.K. through on-line or storefront operations that do not supply legitimate, FDA-approved products, or through state-run drug importation programs that facilitate the purchase of unapproved foreign drugs. Consumers who purchase drugs through these arrangements may have received these counterfeit products.

"Americans need to be very careful when buying drugs outside of the U.S. drug distribution system," said FDA Commissioner Lester M. Crawford.  "The American drug supply system is in fact a very safe one that consumers can count on."

The affected product is 20 mg. "Lipitor" and is sold in packages of 28 tablets.  The drug packages are marked with batch number 004405K1 and an expiration date of "11 2007."  The batch number can be found on the end of the box next to the expiration date and on the foil backing of the drug's blister pack.  Legitimate U.K. Lipitor also has this same batch number. 

Because the recalled Lipitor is fake, there is no guarantee of its quality or effectiveness.  U.S. patients who have the identified U.K. drugs should stop using them and should consult their physician or pharmacist if they have any questions or concerns.  Patients should resume treatment as soon as they can obtain from their doctors or pharmacists a legitimate supply of Lipitor or an equivalent medicine.  When patients resume taking the drug, they should take only the daily dose prescribed and not try to make up for missed doses.

Lipitor belongs to a class of drugs known as "statins". In addition to Lipitor, a number of low-cost FDA-approved generic versions of these drugs are available to consumers. Consumers interested in these options should discuss them with their physicians.

Information on Pfizer's recall of the one batch of Lipitor can be accessed from the following links:

http://www.mhra.gov.uk/news/press_Lipitor_280705.pdf

http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/defmedsrepcen/Lipitor_EL_05_A11Final.pdf

For additional consumer information on counterfeit drugs, visit the following web sites:
FDA Consumer Education for Counterfeit Medicine
www.fda.gov/cder/consumerinfo/counterfeit_text.htm

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