Advisory - "Fu Fang Zaoren Jiaonang": A Potentially Dangerous Product for Pregnant Women

OTTAWA, July 16, 2012 /CNW/ -

Please click here for Chinese version: http://files.newswire.ca/1043/ch.pdf

The issue:

"Fu Fang Zaoren Jiaonang," an unauthorized natural health product promoted for anxiety and/or insomnia, has been removed from sale after testing by Health Canada confirmed the presence of the ingredient L-tetrahydropalmatine that could cause damage to vital organs such as the liver, most notably in pregnant women.

Who is affected:
Canadians using "Fu Fang Zaoren Jiaonang," especially pregnant women.

"Fu Fang Zaoren Jiaonang" was distributed by the company Dong Phuong Trading Co. and found being sold at Fu Ji Herbal, a retail store in Markham, Ontario. Please note that this product may also be sold elsewhere. As of July 10, 2012, Health Canada had received one adverse reaction report associated with the use of this product. The person experienced tiredness, weakness, headaches and nausea

What consumers should do:

• Speak to your healthcare practitioner about any questions or concerns regarding this product.
• Report any adverse reaction you suspect may be related to this product to Health Canada (see below).
• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality.

What Health Canada is doing:

Fu Ji Herbal has given what it says is its remaining stock of "Fu Fang Zaoren Jiaonang" to Health Canada. The Department has been informed that the distributor, Dong Phuong Trading Co.  is no longer in business.

Health Canada would like to remind Canadian retailers that the sale of health products is governed by the Food and Drugs Act and its Regulations, and that selling unauthorized products is against the law. Retailers found selling unapproved products may have them seized by Health Canada or by various law enforcement authorities.

Background:

The amount of L-tetrahydropalmatine in "Fu Fang Zaoren Jiaonang" could cause damage to vital organs such as the liver in adults after approximately 2 weeks of exposure.

Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

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 these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

Également disponible en français

 

PDF available at: http://stream1.newswire.ca/media/2012/07/16/20120716_C8514_DOC_EN_16249.pdf

PDF available at: http://stream1.newswire.ca/media/2012/07/16/20120716_C8514_DOC_EN_16250.pdf

Media Enquiries: 
Health Canada
[phone]

Public Enquiries:
[phone]
1-866 225-0709