Foreign Product Alerts: Esbelin siloutte té, Esbelin siloutte Herbal Blend with L-Carnitine, Esbelder man, Esbelder fem, and Esbelder siloutte

Starting date:

May 1, 2014

Posting date:

May 1, 2014

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Source of alert:

US FDA

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-39293

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Introduction

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.

Affected products

• Esbelin siloutte té
• Esbelin siloutte Herbal Blend with L-Carnitine
• Esbelder man
• Esbelder fem
• Esbelder siloutte

Esbelin siloutte té, Esbelin siloutte Herbal Blend with L-Carnitine, Esbelder man, Esbelder fem, and Esbelder siloutte

Product description

Esbelin siloutte te and Esbelin siloutte Herbal Blend with L-Carnitine are promoted for weight loss.

The recommended use of Esbelder man, Esbelder fem, and Esbelder siloutte are unknown

Hazard identified

The United States Food and Drug Administration warned consumers not to use these products after they were found to contain these undeclared drug ingredients: Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine.

N-Desmethylsibutramin and N-di-Desmethylsibutramine are unauthorized substances that may be similar to sibutramine and may pose similar health risks.

Sibutramine was previously used to treat obesity but 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.

Place of origin

According to the product packaging, the products are manufactured and distributed by Herbal Give Care LLC.

Side effects

In addition to 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

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.

Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.

Background

Drugs and natural health products that are authorized for sale in Canada will have 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 April 15, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Report a health or safety concern

To report a side effect to a health product to Health Canada:

• 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.

Images

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