Archived – 999 Fitness Essence

Starting date:

June 29, 2009

Posting date:

June 29, 2009

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-12000795

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  Media enquiries
• 
  Public enquiries

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

U.S. Food and Drug Administration (FDA)

Product name

999 Fitness Essence

Manufacturer / Place of origin

Unknown

Product description

999 Fitness Essence is promoted as a "natural" or "herbal" dietary supplement used for weight loss.

Reason for warning

The FDA warned consumers not to buy or use 999 Fitness Essence after it was found to contain the undeclared pharmaceutical ingredient sibutramine.

Sibutramine is a prescription drug used to treat obesity. It should only be taken under the supervision of a health care practitioner.

Health Canada is aware that there may be other products on the market labelled with names similar in meaning to 999 Fitness Essence but not necessarily the same ingredients or directions for use. The information in this alert refers only to the product labelled as 999 Fitness Essence. Should Health Canada find this product or other similar products on the Canadian market that pose a health risk, Health Canada will inform Canadians and take appropriate action.

Possible side effects

Side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

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. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709