Milk Allergy Risk Identified in the Natural Health Product: Dophilus Chewable Tablets

Starting date:

July 24, 2009

Posting date:

July 24, 2009

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Allergy Information, Unauthorized products

Audience:

General Public

Identification number:

RA-110002920

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Health Canada is warning Canadians with milk allergies not to use the unauthorized health product, Dophilus Chewable Tablets (90 tablets), labelled as "non-dairy," because they contain trace amounts of milk protein from dairy ingredients used in the production process. In this light, this product is incorrectly labelled as a non-dairy source of probiotic bacteria.

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. Health Canada is aware of one allergic adverse reaction report possibly associated with the use of Dophilus Chewable Tablets. The consumer experienced hives, vomiting, a runny nose and diarrhea. After discontinuation of the product by the consumer, the symptoms cleared.

Consumers with milk allergies should stop using this product immediately and should return it to the point of purchase. Canadians who have used this product and are concerned about their health should consult with a health care professional.

S.I.S.U. Inc., the manufacturer, has initiated a voluntary recall of Dophilus Chewable Tablets. Health Canada is taking steps to confirm that this product has been removed from the Canadian market.

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 the product listed in this Warning being sold in Canada.

Report health or safety concerns

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:

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

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Health Canada
613-957-2983

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

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