Nyal Day & Night Cold & Flu Fighter (AUST L 146264)
Nyal Cold & Flu Fighter (AUST L 146263)

Foreign Product Alert
2009-27
February 25, 2009
For immediate release

Health Canada is advising consumers not to use the following products specified below due to concerns about possible side-effects. More info

Date of alert: February 25, 2009
Source of Alert: Australia Therapeutic Goods Administration
Product Names:
Nyal Day & Night Cold & Flu Fighter (AUST L 146264)
Nyal Cold & Flu Fighter (AUST L 146263)
Manufacturer / Place of Origin: Valeant Pharmaceuticals Australasia Pty Ltd / Rhodes, Australia

Product Description
The two Nyal products listed above are promoted for the relief of cold and flu symptoms.

These products come in packages of 24 tablets. Nyal Day & Night Cold & Flu Fighter is labelled with the product identifier "AUST L 146264," while Nyal Cold & Flu Fighter is labelled with "AUST L 146263."

Reason for Warning
The Australia Therapeutic Goods Administration advised consumers not to use the above two products after they were associated with serious allergic reactions, including life-threatening reactions (anaphylaxis). The products were voluntarily recalled by the manufacturer from the market and consumers were advised to return them to the place of purchase.

The specific cause or ingredient(s) that may have triggered the allergic reactions is unknown. The product labels indicate they contain the herbs Andrographis paniculata (Andrographis), Sambucus nigra (Elderberry) and Salix alba (White willow). In addition, the night-time tablet (Nyal Day & Night Cold & Flu Fighter) contains the herb Valeriana officinalis(Valerian).

Possible Side-Effects
An allergic reaction occurs when the body's immune system reacts to a foreign substance. The reaction can range from mild to life-threatening (anaphylactic reaction).

A mild reaction includes skin rash, sneezing itchy and/or runny eyes and nose. A severe reaction includes swelling, difficulty breathing or swallowing, dizziness, sudden drop in blood pressure and loss of consciousness.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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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 products listed above 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.