Health Canada

Health Canada

June 15, 2010 16:53 ET

Unauthorized Health Products Labelled in Russian, Ukrainian or Kazakh Removed from the Montreal Market

OTTAWA, ONTARIO--(Marketwire - June 15, 2010) -

The issue:

Unauthorized health products that may pose a serious health risk were found on the Montréal market with packaging in Russian, Ukrainian or Kazakh languages only. As a result, important information about the proper use and potential side effects of these products may not be understood by consumers.

The labels of eight of these products (listed below) indicate the products contain ingredients that legally require the products to be sold with a prescription because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner. 

Additional unauthorized health products (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_101bk-eng.php) were also removed from the Montréal market.

Who is affected:

Canadians who have purchased any of these products.

What consumers should do:

• Consult your healthcare practitioner if you have used any of these products and are concerned about your health.

• Read the labelling of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.

• Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing:

The retailers in Montréal have provided these unauthorized products to Health Canada following our inspections. Health Canada has been advised by these retailers that they are no longer distributing these products.

Background:

The ingredients listed on the labels of the eight products can cause serious health problems. If you have taken products containing these ingredients without the supervision of a health care practitioner or without a prescription, you may face additional risks. You may be misdiagnosed, the treatment might not be appropriate for your illness or you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

Consumers should note that there may be authorized alternatives for these products in Canada and any authorized products would be labelled in English and/or French. Consumers are reminded that the names of the unauthorized products that are on the actual labelling of the products are written in Russian, Ukrainian or Kazakh languages only. This labelling can be seen on the photos of the products found at the following address: http://media3.marketwire.com/docs/hela0615.pdf

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and send to us using one of these methods:

  • Fax: 1-866-678-6789
  • E-mail: CanadaVigilance@hc-sc.gc.ca
  • Internet: www.healthcanada.gc.ca/medeffect
  • Mail: Canada Vigilance Program
     Marketed Health Products Directorate
     Ottawa, ON, Address Locator 0701C
     K1A 0K9 

Related Health Canada Web content:

Advisory (June 3, 2010) - OM Fusion: Additional Unauthorized Products Removed from the Canadian Market (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_92-eng.php)

Advisory (February 19, 2010) - Unauthorized OM Fusion Distributors LLC Health Products Found on the Canadian Market (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_23-eng.php)

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories (http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/).

Également disponible en français

Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709