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Foreign Product Alert
2009-93
June 17, 2009
For immediate release
Health Canada is advising consumers not to use the following product listed in the table below due to concerns about possible side-effects.

Source of Alert: U.S. Food and Drug Administration (FDA)
Product Names:
The products (listed with their size and U.S. product numbers) are:
1)
Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
2)
Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
3)
Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)
Manufacturer / Place of Origin:
Matrixx Initiatives, Scottsdale, Arizona, USA

Product Description
Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size
, are promoted as natural, homeopathic remedies used to relieve cold symptoms and to reduce the length and severity of colds.

Reason for Warning
The FDA warned consumers not to buy or use the three
Zicam products listed above, which are all applied nasally, after they were associated with numerous reports of long lasting or permanent loss of smell. In some cases, the condition occurred with the first dose, while others reported loss of smell after multiple uses.

The FDA has initiated a nationwide recall and is advising consumers who have purchased these products to either discard them or return them to the place of purchase.

Possible Side-Effects
The U.S. FDA has received more than 130 reports of the loss of sense of smell associated with the use of these products. The loss of smell, also called anosmia, is a serious adverse reaction that may be irreversible in some cases.


More Info
These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either 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 advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed in the table in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

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