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Foreign product alert

Nyal Day & Night Cold & Flu Fighter, Nyal Cold & Flu Fighter

Starting date:
February 25, 2009
Posting date:
February 25, 2009
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information, Allergy Information
Audience:
General Public
Identification number:
RA-120001026

Source of alert

Australia Therapeutic Goods Administration

Product names

  1. Nyal Day & Night Cold & Flu Fighter (AUST L 146264)
  2. 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.

What you should do

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. Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

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.

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.

Report a health or safety concern

  • Call toll-free at 1-866-234-2345.
  • Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709