Public advisory

OM Fusion: Additional Unauthorized Products Removed from the Canadian Market

Starting date:
June 3, 2010
Posting date:
June 3, 2010
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Unauthorized products, Undeclared Substance
Audience:
General Public
Identification number:
RA-110004360

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

  • Valocormid contains sodium bromide. 
  • Voltaren contains sodium diclofenac.

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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Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

Images

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