Health Canada advises consumers about recall of counterfeit Lipitor sold in the United Kingdom

Advisory
2005-91
August 15, 2005
For immediate release

OTTAWA - Health Canada is advising Canadians about the recent recall of a batch of counterfeit Lipitor (atorvastatin) sold in the United Kingdom (UK). This drug is used to treat high cholesterol. The counterfeit Lipitor 20mg tablets were recalled in the UK on July 28, 2005.

Health Canada has no indication that any of the counterfeit Lipitor tablets reached the Canadian market.

Health authorities in the UK stated that initial results of tests performed on the counterfeit Lipitor do not indicate that this product poses an immediate risk to patients. The affected lot number of the counterfeit Lipitor is 004405K1, with an expiration date of "11 2007."

As a precaution, Health Canada is issuing this advisory to alert the public to this matter, as well as to the potential health risks related to the use of counterfeit drugs in general.

Counterfeit drugs may contain the incorrect dose, the wrong ingredients or no active ingredients at all, resulting in a potentially serious health risks to patients.

Consumers who purchased Lipitor tablets through licenced Canadian pharmacies should not have received any of these counterfeit tablets. If any counterfeit Lipitor tablets are found in Canada, individuals and health professionals are asked to contact the closest Health Products and Food Branch Inspectorate Operational Centre at the numbers listed below.

Consumers are reminded to only use prescription drug products that have been reviewed and authorized for sale by Health Canada, which can be identified by the presence of an eight-digit Drug Identification Number (DIN) on the label.

Consumers should consult with their pharmacist and their 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. See contact information below.

The UK advisory can be found at:

• http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dID=1503&noSaveAs=1&Rendition=WEB

The United States Food & Drug Administration also issued a similar advisory that can be found here:

• http://www.fda.gov/bbs/topics/NEWS/2005/NEW01216.html

Email reports to: cadrmp@hc-sc.gc.ca

Or visit our website:

• http://www.hc-sc.gc.ca/dhp-mps/medeff/advers-react-neg/index-eng.php

Health professionals and consumers may report adverse reactions toll free to Health Canada at:
Tel: 866 234-2345
Fax: 866 678-6789

Mail adverse reaction reports to:
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario
K1A 0K9

Inspectorate Operational Centres:

British Columbia, Alberta, Northwest Territories, Yukon
Operational Manager
4th Floor
4595 Canada Way
Burnaby, British Columbia V5G 4P2
Phone (604) 666-3704 or Fax (604) 666-3149

Manitoba, Saskatchewan
Operational Manager
510 Lagimodiere Blvd
Winnipeg, Manitoba R2J 3Y1
Phone (204) 983-5490 or Fax (204) 984-2155

Ontario, Nunavut
Operational Manager
2301 Midland Ave.
Toronto, Ontario M1P 4R7
Phone (416) 973-1600 or Fax (416) 954-4583

Quebec
Operational Manager
1001 Rue St-Laurent Ouest
Longueuil, Quebec J4K 1C7
Phone (450) 646-1353 or Fax (450) 928-4455

Atlantic
Operational Manager
Suite 1625, 16th Floor
1505 Barrington Street
Halifax, Nova Scotia B3J 3Y6
Phone (902) 426-2160 or Fax (902) 426-6676

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Media Inquiries:
Christopher Williams
Health Canada
(613) 946-4250

Public Inquiries:
(613) 957-2991