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Public advisory

Archived - Counterfeit Toothpaste Falsely Labelled as Colgate Found to Contain Harmful Bacteria

Starting date:: June 29, 2007
Posting date:: June 29, 2007
Type of communication:: Advisory
Subcategory:: Miscellaneous
Source of recall:: Health Canada
Issue:: Contamination, Product Safety, Unauthorized products
Audience:: General Public
Identification number:: RA-110002071

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Health Canada is warning Canadians that counterfeit toothpaste products, falsely labelled as Colgate Fluoride Toothpaste Herbal and Colgate Fluoride Toothpaste Maximum Cavity Protection, have been found to contain high levels of harmful bacteria. These products have been found on the Canadian market and pose a significant risk to health, especially to children and individuals with compromised immune systems. Health Canada is assisting in the criminal investigation that is being conducted by the Royal Canadian Mounted Police.

Potential adverse effects of ingesting products that contain unacceptable amounts of aerobic bacteria include fever, and gastrointestinal symptoms such as vomiting, diarrhea and abdominal pain. Infants and children are more sensitive to these effects and severe vomiting and diarrhea could lead to potentially life-threatening dehydration. While toothpaste is not intended to be swallowed, it is often swallowed by young children.

These counterfeit products were also found to contain a type of bacteria from the Enterobacteriaceae family, which is of particular concern in vulnerable populations such as patients hospitalized for severe underlying diseases or with compromised immune systems. In addition to gastrointestinal illnesses, infections can occur in the lungs and urinary tract, and can cause blood poisoning.

Consumers who have purchased one of these counterfeit toothpaste products are advised to discontinue use immediately. Consumers who have experienced any symptoms after using one of these products, or are concerned about their health, are advised to consult their physician immediately.

The counterfeit products are falsely labelled as Colgate Fluoride Toothpaste Herbal and Colgate Fluoride Toothpaste Maximum Cavity Protection marked as 100 ml. The Colgate Fluoride Toothpaste Maximum Cavity Protection is labelled as "Manufactured in South Africa" and contains misspellings including "isclinically" "SOUTH AFRLCA" and "South African Dental Assoxiation". A third toothpaste, also falsely labelled as Colgate, Fluoride Toothpaste Gel, was confirmed to be counterfeit.

Genuine Colgate toothpaste approved for sale in Canada is safe and is labelled in English and French. Additionally, fluoride-containing toothpaste that has been approved for sale in Canada will contain either an eight-digit Drug Identification Number (DIN) or a Natural Product Number (NPN). None of the three counterfeit brands of toothpaste have a DIN or NPN or have bilingual packaging.

These counterfeit toothpaste products have been found in the discount chain "Everything for a Dollar Store." Canadian distributors are cooperating in the investigation and have removed the product from their shelves.

Consumers who find a health product they believe to be counterfeit for sale in Canada should contact Health Canada's Health Products and Food Branch Inspectorate at 1-800-267-9675.

Canadian consumers with questions on how to identify genuine Colgate toothpaste can contact Colgate Canada's consumer line at (1-800-268-6757) or visit www.colgate.ca.

Consumers are also advised to monitor the Health Canada website for additional updates regarding this issue.

To date, no adverse reactions suspected to be associated with the use of these counterfeit toothpaste products have been reported in Canada. To report a suspected adverse reaction to toothpaste products, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

Email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect Canada area of the Health Canada Web site.