Advisory

2003-51
June 25, 2003
For immediate release

Health Canada alerts Canadians to Pan Pharmaceuticals Ltd. products recall in Australia

OTTAWA - Health Canada is informing Canadians about products manufactured by Pan Pharmaceuticals Ltd. after more than 1500 of them were recalled in Australia. The products, mainly over-the-counter (OTC) herbal and vitamin supplements, were recalled due to serious quality and safety concerns, including the substitution of ingredients and substandard manufacturing processes.

There are no approved products made by Pan Pharmaceuticals Ltd. sold in Canada that carry a Drug Identification Number, the eight-digit number on the label of the product that indicates it has been reviewed and approved by Health Canada for safety and efficacy. However, an unapproved product called New EPA-DHA Extra Strength Enteric-Coated capsules is made by Pan Pharmaceuticals Ltd. and distributed in Canada by Metagenics. As a precaution, the distributor has voluntarily recalled this product from the Canadian market.

In the event that other unapproved products manufactured by Pan Pharmaceuticals Ltd. have entered Canada, Health Canada advises consumers to verify the label of their herbal, vitamin-mineral-supplement, OTC cold/flu, or travel sickness medicines to make sure that "Pan Pharmaceuticals Ltd." does not appear on the label and that it does not appear on the recall list. A list of products recalled in Australia is available at the following web site:
http://www.tga.gov.au/recalls/panrecfull.htm

The following countries have imported Pan Pharmaceutical products: Brazil, Czech Republic, Hong Kong, Indonesia, Ireland, Kuwait, Lebanon, Malaysia, New Zealand, People's Republic of China, Philippines, Singapore, South Africa, Taiwan, Thailand, United Kingdom (UK), United States of America (USA),Vietnam. If consumers have purchased herbal, vitamin-mineral-supplement, OTC cold/flu, or travel sickness medications from any of these countries or Australia, they should check the label of the product to make sure it does not appear on the recall list. A list of recalled products exported to other countries is available at the following web site:
http://www.health.gov.au.

If consumers do have products that appear on the list, they are asked to contact their regional Health Canada Operational Centre with this information. Health Canada reminds consumers to check for a Drug Identification Number (DIN) and to read the label of every product they use.

Health Canada has issued a Customs Alert to prevent the commercial importation of these products.

Health Canada will continue to work with Australia's Therapeutic Goods Administration, and will communicate any new relevant information to the public.

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See the attached TGA website for more details:
http://www.health.gov.au

Health Products and Food Branch Inspectorate Operational Centres

Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335

Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the MedEffect or in The Canadian Compendium of Pharmaceuticals and Specialties.