Dec 24, 2010: Four Probiotic Natural Health Probiotics (CAN)

[hezzier]

http://allergy.hyperboards.com/action/view_topic/topic_id/17600/start/1


UPDATE: OTTAWA, ONTARIO--(Marketwire - Dec. 24, 2010) -

Note that one additional product has been added to this advisory as of December 24, 2010.

The issue:

Consumers with milk or soy allergies are advised that four probiotic natural health products (listed below) are being voluntarily recalled from the market because they are labelled as not containing dairy(milk) and/or soy but may contain trace amounts of milk or soy protein from ingredients used in the production process.

People with allergies to milk or soy can experience a range of mild to severe symptoms when exposed to even small amounts of milk or soy proteins. These symptoms may include breathing difficulties that, in some cases, can be life threatening. It is important to note that no adverse reactions involving these products have been reported to Health Canada.

Who is affected:

Canadians with milk or soy allergies who have purchased or used any of the four products listed below.

What consumers should do:

Speak to your healthcare practitioner with any questions or concerns regarding further use of these products.

Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing:

Health Canada will monitor the company recalls and work with the companies to ensure these products are appropriately labelled.

Background:

Live microorganisms, including probiotics, that are included in natural health products are grown in nutrient solutions called culture media. The culture media used to produce probiotics include a source of protein, which is frequently but not always derived from milk or soy, which are both priority allergens in Canada. For products that are formulated as pills or dry powders, the culture media is mostly removed before freeze-drying. Because culture media is removed, it is not considered to be a non-medicinal ingredient and is not required to be listed on product labels. However, traces of milk, soy or any other priority allergen included in culture media that was removed can remain in the product in quantities sufficient to provoke an allergic reaction in highly sensitive individuals.

Products that have been assessed by Health Canada for safety, effectiveness and quality 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. The products being recalled have NPNs, as indicated below.

Products affected:

The four products are promoted as natural health products that contain live bacteria (probiotics) for therapeutic purposes.

To view the table of the different products, please visit the following link: http://media3.marketwire.com/docs/tableau_health_canada_eng_1224.pdf

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 report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

Fax: 1-866-678-6789

Internet: http://www.healthcanada.gc.ca/medeffect

Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9

Related Health Canada Web content:

- Advisory (December 6, 2010) ─ "Probiophilus" and "Cultures de Yogourt 5 Milliards" May Pose Serious Health Risks to Canadians with Milk Allergies (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_216-eng.php)

- Warning (July 24, 2009) ─ Milk Allergy Risk Identified in the Natural Health Product: Dophilus Chewable Tablets (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_120-eng.php)

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories (http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/).

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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For more information, please contact

Media Inquiries:
Health Canada
613-957-2983
or
Public Inquiries:
613-957-2991
1-866-225-0709