"Complete 7-Day Cleanse" Recalled Due to Possible Serious Health Risks

Advisory
2010-19
February 9, 2010
For immediate release

OTTAWA - Health Canada is advising consumers that the unauthorized product "Complete 7-Day Cleanse" is being recalled because it contains a number of active ingredients with a combined effect that may pose serious health risks. "Complete 7-Day Cleanse" is a multi-ingredient natural health product promoted for "cleansing" or removing toxins from the body.

According to package labelling, the product contains over 30 active ingredients, some having a diuretic (water pill) or laxative (stimulant, and bulk-forming) effect. This combination of ingredients may increase the laxative or diuretic impact of the product and pose a risk of dehydration and/or electrolyte imbalance.

Symptoms of severe dehydration may involve an altered mental state and dizziness. Symptoms of moderate to severe electrolyte imbalance (which is an imbalance of salts in the body, such as potassium or sodium) may include muscle weakness or cramping, abnormal heartbeat, and difficulties breathing.

The product is available at retail outlets across Canada and over the Internet. The Canadian importer, Iovate Health Sciences International Inc., of Oakville, Ontario, has initiated a nationwide recall at the request of Health Canada.

Canadians who have used "Complete 7-Day Cleanse" and are concerned about their health should speak to a health care practitioner. Individuals should be aware of signs or symptoms of dehydration or electrolyte imbalance, as described above.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label. This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.

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.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to:
    Canada Vigilance Program
    Health Canada
    AL 0701D
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

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Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709