Health Canada

Health Canada

December 06, 2010 15:45 ET

"Probiophilus" and "Cultures de Yogourt 5 Milliards" May Pose Serious Health Risks to Canadians With Milk Allergies

OTTAWA, ONTARIO--(Marketwire - Dec. 6, 2010) -

The issue:

Two separate natural health products labelled as non-dairy, "Probiophilus" and "Cultures de Yogourt 5 Milliards", are being voluntarily recalled from the Canadian market by Les Importations Herbasanté Inc. and and Bio-Dis Inc. respectively because they may contain trace amounts of milk protein from dairy ingredients used in the production process.

Individuals with milk allergies can experience a variety of symptoms when exposed to even small amounts of milk proteins. These symptoms include breathing difficulties which in some cases can become fatal. It is important to note that no associated adverse reactions to either of these products have been reported to Health Canada.

Who is affected:

Canadians who have milk allergies and have purchased or used "Probiophilus" (NPN 80016388) or "Cultures de Yogourt 5 Milliards" (NPN 80013135).

What consumers should do:

• Consumers with milk allergies who have used either of these products should immediately consult with their healthcare practitioner regarding any further use of these products.

• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. 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 NHPs may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is in progress of reviewing their application for licensing.

• Report any adverse reaction potentially related to this product to Health Canada (see below).

What Health Canada is doing:

Health Canada will monitor the recalls by Les Importations Herbasanté Inc (Probiophilus) and Bio-Dis Inc (Cultures de Yogourt 5 Milliards).

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.

When live microorganisms, including probiotics, are prepared by a third-party manufacturer, licence-holders may not be informed by the manufacturer that the raw material has come into contact with a priority allergen during manufacturing because the culture media is not considered to be an ingredient. Licence-holders may incorrectly assume that raw materials without milk or soy listed as ingredients are dairy-free or soy-free and actively market products that have come into contact with a priority allergen to sensitive individuals.

Images of the affected products are available here: http://media3.marketwire.com/docs/product1.jpg

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 the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

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

Related Health Canada Web content:

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

Egalement disponible en francais

Contact Information

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