Do Not Use A Specific Lot Of Neutragel Sodium Fluoride Gel Due To Mould Contamination, Health Canada Tells Consumers

Main Category: Dentistry
Article Date: 25 Oct 2006 - 14:00 PDT

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Health Canada is advising consumers that certain bottles of Neutragel, a sodium fluoride gel, have been contaminated with mould. This anti-cavity dental product is commonly used by patients with weakened immune systems, patients with diabetes, dry mouth, undergoing chemotherapy, or for tooth decay caused by radiation. This sodium fluoride gel is administered in a dental office or at home.

Although the product is not likely to pose serious health concerns, Health Canada advises consumers to stop using the product immediately and to contact their physician or dentist if they show signs of fever, oral lesions or redness of the gums after using Neutragel.

The manufacturer of Neutragel, Germiphene Corporation, has recalled the product. If you have this product, it should be returned to the place of purchase. The Drug Identification Number (DIN) for Neutragel is 01922017 and can be found on the product label. The affected lot number of the product is 60372 with an expiry date of March 2008, both of which are also located on the product label.

Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction with this or any other health product, 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
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
email: cadrmp@hc-sc.gc.ca

Health Canada

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