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OM Fusion: Additional Unauthorized Products Removed from the Canadian Market
Advisory
2010-92
June 3, 2010
For immediate release
The issue
Following a February 2010 Advisory concerning unauthorized products sold under the OM Fusion Distributors LLC label, additional unauthorized products with the OM Fusion label have been removed from the Canadian market by Health Canada.
The labels for Valocormid and Voltaren indicate the products contain ingredients that legally require the products to be sold by prescription because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner. Additional unauthorized OM Fusion health products were sold in Canada 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.
Who is affected
Canadians who have purchased any OM Fusion 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
Following Health Canada inspections of warehouses and retailers in Montréal and Toronto, these unauthorized health products are no longer on the Canadian market. Health Canada has also been advised that these unauthorized products are no longer being distributed by these warehouses.
Background
The ingredients listed on the label of the Valocormid and Voltaren 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 to treat your illness and you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.
Products affected
- 1. Valocormid contains sodium bromide.
- 2. Voltaren contains sodium diclofenac.
- 3. View the additional unauthorized products
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 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
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