The US FDA is alerting US residents to the recent recall of a batch of counterfeit Lipitor (atorvastatin) sold in the United Kingdom (UK). The medicine is used to treat high cholesterol.

The counterfeit Lipitor 20mg tablets were recalled in the UK on July 28, 2005. Health authorities in the UK 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. UK 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 US pharmacies should not have received any of these counterfeit tablets and are not subject to this recall. But some US residents may have obtained prescription drugs from the UK 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, said an FDA release.

"Americans need to be very careful when buying drugs outside of the US drug distribution system," said FDA Commissioner Lester M. Crawford.

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. Legitimate UK Lipitor also has this same batch number, the release added.

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.