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Foreign product alert

Foreign Product Alerts: ESV Extra Strong Version, MSV Strong Version, RL Rapid Loss, My Slimmer Me (MSM) soft gel capsules, Natural Miaotiaoyishen capsules, and Paiyouji Natural Slimming Capsules

Starting date:: November 8, 2013
Posting date:: November 8, 2013
Type of communication:: Foreign Product Alert (FPA)
Subcategory:: Natural health products
Source of recall:: Health Canada
Issue:: Undeclared Substance
Identification number:: RA-36521

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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

ESV Extra Strong Version soft gel capsules
MSV Strong Version soft gel capsules
RL Rapid Loss soft gel capsules
My Slimmer Me (MSM) soft gel capsules
Natural Miaotiaoyishen capsules
Paiyouji Natural Slimming Capsules

ESV Extra Strong Version, MSV Strong Version, RL Rapid Loss, and My Slimmer Me (MSM) soft gel capsules

Product description

These products are promoted for weight loss.

Hazard identified

The Australia Therapeutic Goods Administration warned consumers not to use these products as they were found to contain sibutramine and a sibutramine impurity, drug ingredients that were not declared on the labels.

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

ESV Extra Strong Version, MSV Strong Version, RL Rapid Loss are distributed by GNY Australia. The origin of My Slimmer Me (MSM) soft gel capsules 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.

The side effects of the sibutramine impurity are unknown.

Natural Miaotiaoyishen

Product description

This product is promoted as a natural product. Its use is unknown.

Hazard identified

The Australia Therapeutic Goods Administration warned consumers not to use this product as it was found to contain phenolphthalein and sibutramine, drug ingredients that were not declared on the label.

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

Unknown

Side effects

Additional side effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

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.

Paiyouji Natural Slimming Capsules

Product description

This product is promoted for weight loss.

Hazard identified

The Australian Therapeutic Goods Administration warned consumers not to use this product after it was found to contain undeclared sildenafil and phenolphthalein.

Sildenafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a healthcare professional.
Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer.

Place of origin

Distributed by MAH Co, USA.

Side effects

Sildenafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Additional side effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

What you should do

Canadians who possess any of the products listed above are advised not to use them, and should consult with a health care professional if they have concerns about their health related to the use of these products. Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products 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 Octobe 25, 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

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