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Foreign product alert

Foreign Product Alerts: 14 sexual enhancement products

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
Audience:: General Public
Identification number:: RA-36233

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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

SexVoltz (Regular and Maximum Strength)
Velextra (Regular and Maximum Strength)
Amerect* (Regular and Maximum Strength)
Night Bullet
Bullet Proof
Vicerex
Zoom-Zooma-Zoom
Sex Plus
Affirm XL
Ninja Mojo
Love Rider
Stiff Days
ROCK-IT MAN
Libido Sexual Enhancer

SexVoltz, Velextra and Amerect

Product description

These products are promoted for sexual enhancement. They come packaged in blister type packaging of 1 or 2 capsules, and in bottles of 4, 10 or 12 capsules.

Hazard identified

The U.S. Food and Drug Administration informed the public of the voluntary recall of the products SexVoltz, Velextra and Amerect* because “SexVoltz” and “Velextra” were found to contain tadalafil, a drug ingredient that was not declared on the product labels.

Tadalafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a healthcare professional.

*The product “Amerect” was not tested; however, it was also voluntarily recalled by the manufacturer because it has the potential to contain undeclared tadalafil.

Place of origin

These products are manufactured by BeaMonstar Products, of Queen Creek, AZ, U.S.A.

Side effects

Tadalafil 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.

Night Bullet

Product description

This product is promoted for sexual enhancement.

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use this product as it was found to contain aminotadalafil and sulfohydroxyhomosildenafil, drug ingredients that were not declared on the label.

Aminotadalafil and sulfohydroxyhomosildenafil are substances similar to tadalafil and sildenafil, respectively, which are drugs used to treat erectile dysfunction and should only be taken under the supervision of a healthcare professional.

Place of origin

Green Planet, Inc. of Riverside, CA, U.S.A.

Side effects

Both aminotadalafil and sulfohydroxyhomosildenafil are substances similar to tadalafil and sildenafil, respectively. Sildenafil and tadalafil should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they 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.

Bullet Proof, Vicerex, Zoom-Zooma-Zoom, and Sex Plus

Product description

These products are promoted for sexual enhancement.

Hazard identified

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

Bullet Proof and Vicerex were found to contain tadalafil while Zoom-Zooma-Zoom was found to contain sildenafil. Sex Plus was found to contain sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil.

Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction. They should only be taken under the supervision of a healthcare professional.
Sulfosildenafil and dimethylacetildenafil are unauthorized substances similar to sildenafil and may pose similar health risks.

Place of origin

Unknown

Side effects

Sildenafil and tadalafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as they 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.

Sulfosildenafil and dimethylacetildenafil are unauthorized substances similar to sildenafil.

Affirm XL

Product description

This product is promoted for sexual enhancement. It comes packaged in 10 count blister packs and single pill packs.

Hazard identified

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

Sulfoaildenafil is an unauthorized substance similar to sildenafil, a prescription drug used to treat erectile dysfunction and may pose similar health risks. Sildenafil should only be taken under the supervision of a healthcare professional.

Place of origin

Distributed by Affirm XL, Inc., and manufactured by Dongseo Biopharm Corp.

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.

Ninja Mojo and Love Rider

Product description

These products are promoted for sexual enhancement.

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use these products after they were found to contain tadalafil, a drug ingredient that was not declared on the product label.

Tadalafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a healthcare professional.

Place of origin

Ninja Mojo is distributed by Ninja America Inc.

Love Rider is distributed by Nutratech INC.

Side effects

Tadalafil 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.

Stiff Days, ROCK-IT MAN and Libido Sexual Enhancer

Product description

These products are promoted for sexual enhancement.

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use these products after they were found to contain one or more of the following drug ingredients that were not declared on the label: sildenafil, tadalafil, hydroxythiohomosildenafil, and hydroxyhomosildenafil.

Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction. They should only be taken under the supervision of a healthcare professional.
Hydroxythiohomosildenafil and hydroxyhomosildenafil are unauthorized substances similar to sildenafil and may pose similar health risks.

Place of origin

ROCK-IT MAN is distributed by Consumer Concepts

The origin of Stiff Days and Libido Sexual Enhancer is unknown.

Side effects

Sildenafil and tadalafil 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.

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 October 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