Weight loss aids, various brands and manufacturers

Starting date:

December 21, 2012

Posting date:

December 21, 2012

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance

Audience:

General Public

Identification number:

RA-16375

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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

Product names

• Tianji True Slim
• Ultimate Formula Bee Pollen Capsules, also referred to as Ultimate Formula
• Zi Xiu Tang Bee Pollen Capsules (available in Classic, Regular or Extra Strength varieties), also referred to as Zi Xiu Tang Beauty, Face & Figure Capsules
• Beautiful Slim Body
• Best Share Green Coffee: Brazilian Slimming Coffee
• Japan Hokkaido Slimming Weight Loss Pills

Manufacturer / Place of origin

Tianji True Slim is manufactured by American Quality Herbs, Inc.

Ultimate Formula and Zi Xiu Tang Bee Pollen Capsules are manufactured by GuangZhou Zi Xiu Tang Biotechnology Co. Ltd. of China and distributed in the U.S. by Zi Xiu Tang Success, LLC.

The manufacturers of the other products are unknown.

Product description

These products are marketed mainly as weight loss aids.

Reason for warning

The U.S. Food and Drug Administration (FDA) warned consumers not to purchase or use these products after they were found to contain the undeclared drug ingredient sibutramine.

The U.S. distributor for Ultimate Formula and Zi Xiu Tang Bee Pollen Capsules subsequently issued a voluntary recall for certain lots of these products.

Sibutramine, a former prescription drug previously used to treat obesity, is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side-effects such as heart attack and stroke.

The following lots of Classic Zi Xiu Tang Bee Pollen Capsules, in bottles of 60 capsules, were recalled:

Lot #	Exp. Date	UPC Code
04/15/2012	04/15/2014	6937000700019
05/15/2012	05/15/2014	6937000700019
06/15/2012	06/15/2014	6937000700019
07/15/2012	07/15/2014	6937000700019

The following lots of Ultimate Formula, in bottles of 48 capsules, were recalled:

Lot #	Exp. Date	UPC Code
05/25/2012	05/24/2014	793573041401
07/29/2012	07/28/2014	793573041401
08/05/2012	08/04/2014	793573041401

Possible side effects

In addition to an increased risk of heart attack and stroke, 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

Health Canada

613-957-2983

Images

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