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Public advisory

Unauthorized OM Fusion Distributors LLC Health Products Found on the Canadian Market

Starting date:: February 19, 2010
Posting date:: February 19, 2010
Type of communication:: Advisory
Subcategory:: Natural health products
Source of recall:: Health Canada
Issue:: Important Safety Information, Unauthorized products
Audience:: General Public
Identification number:: RA-110004075

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This document has been updated by an advisory dated June 3, 2010.

Health Canada is warning consumers of unauthorized health products sold under the OM Fusion Distributors LLC label included in the table below. The use of these products may cause life threatening reactions. There are serious risks with taking unauthorized drugs without supervision by a health care professional. If you take these products, you may also prevent your physician from properly diagnosing your condition and prescribing the correct medication.

Canadians who have purchased or used these products bearing the OM Fusion label are advised to immediately consult a health care practitioner. Consumers are advised to monitor the Health Canada Web site for additional updates regarding this issue.

The manufacturer packaging for the seven unauthorized products list certain ingredients that are drugs. These ingredients should only be sold with a prescription and are intended for use under the supervision of a health care professional only. It is illegal to sell to the public a product containing these ingredients unless the sale is made pursuant to a prescription.

Each of these unauthorized pharmaceutical products have the same identifying image on their label (below) and have been sold without a prescription. The OM Fusion Distributors LLC label appears as a white sticker on top of the standard manufacturer packaging and falsely represents the prescription drugs as natural health products, such as skin care cream and dietary supplements.

The seven products detailed below are not authorized for sale in Canada and have been voluntarily forfeited to Health Canada by some retailers. These products were sold in Canada with manufacturer packaging that is labelled in only Russian, Ukrainian and Kazakh languages without English and/or French labelling. As a result, pertinent information about usage, dosage and side effects may not be available to the consumer.

Unauthorized Health Products Displaying OM Fusion Distributors LLC label
Product	Reported Drug Ingredient(s)
Adelphane - Esidrex	Hydrated Dihydralazine Sulphate
Antihemorroi Ointment	Betamethasone Valerate
Erythromycin	Erythromycin
Ftorocort	Triamcinolone Acetonide
Levomycetin	Chloramphenicol
Prednisolonum	Prednisolonum
Ampicillin - Zdorovye	Ampicillin

Consumers should exercise caution when purchasing health products. Consumers are reminded that health products that are authorized for sale in 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. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada reminds retailers that the sale of unauthorized drugs contravenes the Food and Drugs Act. Sale of unauthorized drugs could render the seller liable for conviction for an offence under the Act. As such, Health Canada advises retailers to remove these products from their shelves and contact the Health Products and Food Branch Inspectorate for more information .

Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate if they find these brands of products for sale in Canada. Complaints involving OM Fusion Distributors LLC can be reported to the Health Products and Food Branch Inspectorate 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

Or by E- mail: DCVIU_UVCEM@hc-sc.gc.ca

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect™Canada section of the Health Canada website
Call toll-free: 1-866-234-2345
Complete a Canada Vigilance Reporting Form and either:
- Fax toll-free: 1-866-678-6789
- Mail to: Canada Vigilance Program
  Health Canada
  AL 0701D
  Ottawa, ON K1A 0K9