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Public advisory

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

Starting date:
December 6, 2010
Posting date:
December 6, 2010
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Product withdrawal, Undeclared Substance
Audience:
General Public
Identification number:
RA-110003995

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.

Products affected

  • "Probiophilus" 
  •  "Cultures de Yogourt 5 Milliards"
  

How to report side effects to health products

To a 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 it to us using one of these methods:

  • Fax: 1-866-678-6789
  • E-mail: CanadaVigilance@hc-sc.gc.ca
  • Internet: www.healthcanada.gc.ca/medeffect
  • Mail: Canada Vigilance Program
    Marketed Health Products Directorate
    Ottawa, ON, Address Locator 0701C
    K1A 0K9

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

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