OTTAWA – Health Canada is informing consumers about a batch
of counterfeit Lipitor (the brand name for atorvastatin) found on the market in
the United Kingdom. This drug is used to treat high cholesterol. The counterfeit
Lipitor has a lot number of 004405K1, with an expiration date of "11 2007."
The counterfeit Lipitor was originally removed from the market in the U.K. on
July 28, 2005, but the product was recently found there again in a pharmacy.
While Health Canada has no indication that any of the counterfeit Lipitor
tablets have reached the Canadian market, the product may have been brought into
Canada by travellers or been purchased over the Internet.
Health authorities in the U.K. said initial test results indicate that the
counterfeit Lipitor does not pose an immediate risk to patients.
As a precaution, Health Canada is issuing this Information Update to alert
the public to this matter, as well as to the potential health risks related to
counterfeit drugs in general.
Counterfeit drugs may contain the incorrect dose, the wrong ingredients,
dangerous additives, or no active ingredients at all, which could result in
potentially serious health risks to patients. Even if these drugs do not harm
you directly or immediately, your condition may get worse without effective
In order to minimize the risk of purchasing counterfeit drugs, consumers who
choose to purchase their medication via the Internet should not do business with
any Web site or company that:
- refuses to give a street address, telephone number or way of contacting a
- offers prescription drugs without a prescription;
- offers to issue a prescription based on answers to an online
- claims to have a "miracle cure" for any serious condition; or
- sells products that are not approved for sale in Canada.
All drugs approved for sale in Canada will bear an eight-digit Drug
Identification Number (DIN). This authorization indicates that the product has
been assessed by Health Canada for safety, efficacy and quality.
Consumers who purchased Lipitor tablets through licensed Canadian pharmacies
should not have received any of these counterfeit tablets.
Consumers should consult with their pharmacist or physician if they have
experienced any adverse effects from taking Lipitor tablets (or atorvastatin,
the active ingredient in Lipitor). Health Canada also encourages health care
professionals and consumers to report any suspected adverse reactions associated
with the use of a product.
Health Canada advises Canadians to contact the Health Products and Food
Branch Inspectorate at 1-800-267-9675 if they believe they have a counterfeit
version of this product.
Consumers requiring more information about this Information Update can
contact Health Canada's public enquiries line at (613) 957-2991, or toll free at
To report a suspected adverse reaction with this or any other health product,
please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of
Health Canada by one of the following methods:
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
02 August 2006