OTTAWA, ONTARIO -- (Marketwired) -- 08/23/13 -- The issue:
Health Canada is warning consumers that dangerous unauthorized health products labeled as being distributed by "OM Fusion Distributors LLC" were once again found on the Canadian market. The Slavic Store, 17107 James McKevitt Road SW (suite 30), Calgary were selling "OM Fusion" products and other unauthorized health products (see below), including antibiotics, antifungal and anti-inflammatory drugs that may pose serious health risks.
The packaging, labeled in only Russian, Ukrainian or Kazakh languages, identifies ingredients in some of these products that should be sold with a prescription and under the supervision of a health care professional only. There were also unauthorized "over the counter" drugs and medical devices being sold at this retail location. As a result, information about usage, dosage and side effects may not be understood by all consumers.
Who is affected:
Canadians who have purchased or used the products pictured below are advised to immediately consult a health care professional.
What consumers should do
- Contact your healthcare professional with any questions or concerns regarding the use of any of these products.
- Read the label of the health 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.
- Report the sale of unauthorized products to Health Canada.
What Health Canada is doing:
The unauthorized products have been removed from sale at the Slavic Store, in Calgary.
Health Canada reminds retailers that the sale of unauthorized drugs and medical devices contravenes the Food and Drugs Act. Unauthorized drugs must not be sold in Canada.
Background:
In certain cases, without the supervision of a health care professional, or without a prescription, some of the products may cause serious health risks, including harmful drug interactions or side effects.
A number of the unauthorized product packages are labeled as being distributed by OM Fusion Distributors LLC, Vista or EDMAR Holdings, LLC. These labels appear as a white sticker on top of the other labeling. Underneath the label, the packaging is labeled in only Russian, Ukrainian and Kazakh languages.
Products affected:
Please visit the Healthy Canadians website for product photos.
For more information:
Complaints involving OM Fusion Distributors LLC, Vista or EDMAR Holdings, LLC can be reported to Health Canada by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate Health Canada Address Locator: 2003C Ottawa, Ontario K1A 0K9
How to report side effects to health products to Health Canada:
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
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Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
