Foreign Product Alerts: Bethel 30, Bethel Advance, Quick Thin, JaDera, Xiyouji Qingzhi, Extreme Body Slim, Paiyouji Plus, Fat Zero, Fruit & Plant Slimming, and Strawberry Balance

Starting date:

February 7, 2014

Posting date:

February 7, 2014

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-37717

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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

• Bethel 30
• Bethel Advance
• Quick Thin
• JaDera
• Xiyouji Qingzhi
• Extreme Body Slim
• Paiyouji Plus
• Fat Zero
• Fruit & Plant Slimming
• Strawberry Balance

Bethel 30, Bethel Advance, Quick Thin, Extreme Body Slim, Payouji Plus, Fat Zero, Fruit & Plant Slimming, and Strawberry Balance

Product description

These products are promoted for weight loss.

• Bethel 30 comes packaged in white plastic bottles containing 30 green capsules. The recalled lot bears Lot # 120514 with expiry date 12/05/2014.
• Bethel Advance comes packaged in white plastic bottles containing 30 white capsules. The recalled lot bears Lot # 10092011 with the expiry date 2014.
• Quick Thin comes packaged in white plastic bottles containing 30 gold capsules. The recalled lot bears Lot # 10032011 with the expiry date 10/2014.
• Extreme Body Slim
• Payouji Plus
• Fat Zero
• Fruit & Plant Slimming
• Strawberry Balance

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use these products after they were found to contain sibutramine and phenolphthalein, drug ingredients that were not declared on the label.

• 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.
• Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer.

Place of origin

Bethel 30, Bethel Advance and Quick Thin are distributed by Bethel Nutritional Consulting, Inc., New York, NY, U.S.A.

Extreme Body Slim, Payouji Plus, Fat Zero, Fruit & Plant Slimming, and Strawberry Balance - place of origin is unknown.

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.

In addition to cancer, side effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

JaDera and Xiyouji Qingzhi

Product description

These products are promoted for weight loss.

• JaDera comes packaged in bottles of 30 capsules.
• Xiyouji Qingzhi comes packaged in bottles of 30 x 300mg capsules.

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use this product after it was found to contain sibutramine, a drug ingredient that was not declared on the label.

• 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

Dolphin Intertrade Corp., of Miami, Florida, U.S.A.

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 any of the products 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 December 31, 2013, 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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