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:
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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:
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
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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
(613) 957-2983
Public Enquiries:
(613) 957-2991
1-866 225-0709
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