Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Update: Four Probiotic Natural Health Products May Pose Serious Health Risks to Canadians with Milk or Soy Allergies

Starting date:
December 24, 2010
Posting date:
December 24, 2010
Type of communication:
Advisory
Subcategory:
Allergen - Milk, Allergen - Soy, Natural health products
Source of recall:
Health Canada
Issue:
Allergy Information, Product withdrawal, Labelling and Packaging
Audience:
General Public
Identification number:
RA-110004070

Issue

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

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.

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

What you 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).

Who is affected

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

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.

Affected products

A. Saccharomyces Boulardii

Product description

Oral capsule

Hazard identified

Product claims to not contain soy but has come into contact with soy during manufacturing.

Code(s) on product

NPN 80013551

Place of origin

Advanced Orthomolecular Research Inc. (AOR)


B. Herbasaurs Bifidophilus for Kids

Product description

Oral capsule

Hazard identified

Product claims to not contain dairy but has come into contact with dairy during manufacturing.

Code(s) on product

NPN 80015508

Place of origin

Nature's Sunshine Products of Canada Ltd.


C. Acidophilus Bifidobacterium

Product description

Oral capsule

Hazard identified

Product claims to be dairy free but has come into contact with dairy during manufacturing.

Code(s) on product

NPN 80015336

Place of origin

Nature's Sunshine Products of Canada Ltd.


D. Cultures de Yogourt 2 Milliards

Product description

Oral capsule

Hazard identified

Product claims to be dairy free but has come into contact with dairy during manufacturing.

Code(s) on product

NPN 80013273

Place of origin

Bio-Dis Inc.


Report health or safety concerns

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

Media enquiries

Health Canada
613-957-2983

Public enquiries

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

What Health Canada is doing

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

Images

Select thumbnail to enlarge - opens in a new window