Ottawa, ON – Aug. 8, 2008 – Health Canada is warning Canadians with milk allergies not to use several brands of unauthorized acidophilus-containing health products labelled as "non-dairy" because they contain trace amounts of milk protein from dairy ingredients used in the production process. The products are:
– Truly Premium All Naturals Acidophilus with Bifidus (50 capsules)
– London Naturals Acidophilus with Bifidus (90 capsules)
– London Naturals Acidophilus with Bifidus (180 capsules)
– London Naturals Acidophilus with Bifidus (30 capsules)
– Acidophilus with Bifidus & FOS – Webber Naturals (180 capsules)
– Acidophilus with Bifidus & FOS – Webber Naturals (60 capsules)
– Rexall Pro-Biotic (60 capsules)
Individuals with milk allergies can experience a variety of symptoms when exposed to even small amounts of milk proteins, including breathing difficulties which in some cases can become fatal. Health Canada is aware of a Canadian case of anaphylactic reaction possibly associated with the use of one of these products.
Consumers with milk allergies should stop using these products immediately and should return them to the point of purchase. Canadians who have used these products and are concerned about their health should consult with a health care professional.
Natural Factors Ltd., the packager and labeller, has initiated a voluntary recall of these products. Health Canada is taking steps to confirm that these products have been removed from the Canadian market.
Acidophilus and bifidus are common ingredients of probiotics, which are live microorganisms that provide a health benefit to the host when administered in sufficient quantities.
Authorized health products will bear an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM). This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.
Consumers should contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find any of the products listed in this Warning being sold in Canada.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345Facsimile: 1-866-678-6789
Canada Vigilance ProgramMarketed Health Products DirectorateOttawa, Ontario, AL 0701CK1A 0K9
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect Canada (www.healthcanada.gc.ca/medeffect) area of the Health Canada Web site.