Foreign Product Alerts: Gold Vigra, Liu Bian Li, GoldReallas, Black Ant Strong, My Man His Enhancer 12 Pack, Top Man 3, Vigour 800, Dick's Hard Up, P-Boost, NatuRECT, 3 Hard Knights, Germany Niubian, and Alpha Male REDDES (or REDDIES), The Rock, Full Throttle On Demand, RezzRX, Play Hard for Men, Rhino 5 Plus, Maxtremezen, Extenzone

Starting date:
September 5, 2014
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs, Natural health products
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-41315

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

  • Gold Vigra
  • Liu Bian Li
  • GoldReallas
  • Black Ant Strong
  • My Man His Enhancer 12 Pack
  • Top Man 3
  • Vigour 800
  • Dick's Hard Up
  • P-Boost
  • NatuRECT
  • 3 Hard Knights
  • Germany Niubian
  • Alpha Male
  • REDDES (or REDDIES)
  • The Rock
  • Full Throttle On Demand
  • RezzRX
  • Play Hard for Men
  • Rhino 5 Plus
  • Maxtremezen
  • Extenzone

Gold Vigra, Liu Bian Li, GoldReallas, Black Ant Strong, My Man His Enhancer 12 Pack, Top Man 3 and Vigour 800

Product description

These products are promoted for sexual enhancement.

Hazard identified

The United States Food and Drug Administration (FDA) warned consumers not to use the products Gold Vigra, Liu Bian Li and GoldReallas, and the Australian Therapeutic Goods Administration (TGA) warned consumers not to use the products Black Ant Strong, My Man His Enhancer 12 Pack, Top Man 3 and Vigour 800, after they were found to contain sildenafil.

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

Place of origin

Unknown

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.

Dick's Hard Up, P-Boost, and NatuRECT

Product description

These products are promoted for sexual enhancement.

Lot# F51Q of both P-Boost and NatuRECT are affected and are packaged in single-capsule blister packs and 5-, 10-, 20-, and 40-capsule bottles.

Hazard identified

The United States Food and Drug Administration (FDA) warned consumers not to use these products after they were found to contain tadalafil.

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

Place of origin

Tendex (Los Angeles, CA) for the products P-Boost and NatuRECT

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.

3 Hard Knights

Product description

This product is promoted for sexual enhancement.

Hazard identified

The United States Food and Drug Administration (FDA) warned consumers not to use this product after it was found to contain sildenafil and thiosildenafil.

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

Place of origin

Unknown

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.

Germany Niubian

Product description

This product is promoted for sexual enhancement.

Hazard identified

The Australian Therapeutic Goods Administration (TGA) warned consumers not to use the product after it was found to contain sildenafil and zopiclone.

  • Sildenafil is a prescription drug used to treat erectile dysfunction.
  • Zopiclone is a prescription drug used to treat insomnia.

Prescription drugs should only be taken under the supervision of a healthcare professional.

Place of origin

Unknown

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.

Side effects associated with zopiclone include unpleasant taste, drowsiness, dizziness, memory loss and hallucinations.

Alpha Male

Product description

This product is promoted for sexual enhancement.

Hazard identified

The United States Food and Drug Administration (FDA) warned consumers not to use this product after it was found to contain sildenafil, aminotadalafil, sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, and dimethylsildenafil

  • Aminotadalafil is an unauthorized substance similar to tadalafil, and sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil and dimethylsildenafil are unauthorized substances similar to sildenafil.
  • Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction and should only be taken under the supervision of a healthcare professional.

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.

REDDES (or REDDIES) and The Rock

Product description

These products are promoted for sexual enhancement.

Hazard identified

The Australian Therapeutic Goods Administration (TGA) warned consumers not to use these products after they were found to contain sulfosildenafil and hydroxyhomothiosildenafil.

  • Sulfosildenafil and hydroxyhomothiosildenafil are unauthorized substances 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

Unknown

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.

Full Throttle On Demand

Product description

This product is promoted for sexual enhancement.

Hazard identified

The United States Food and Drug Administration warned consumers not to use this product after it was found to contain propoxyphenyl sildenafil.

  • Propoxyphenyl sildenafil 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

Unknown

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.

RezzRX

Product description

This product is promoted for sexual enhancement.
The affected lots are Lot QL110714A102 Exp 11/2013, which is packaged in a 20-count white bottle containing 20 yellow capsules, and Lot QL110408B046 Exp 06/2015, which is packaged in single blister cards containing one yellow capsule.

Hazard identified

The United States Food and Drug Administration warned consumers not to use this product after it was found to contain hydroxythiohomosildenafil and/or aminotadalafil.

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

Place of origin

Fossil Fuel Products, LLC

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.

Play Hard for Men

Product description

This product is promoted for sexual enhancement.

Hazard identified

The Australian Therapeutic Goods Administration (TGA) warned consumers not to use this product after it was found to contain yohimbine and hydroxyhomothiosildenafil.

  • Yohimbine is a prescription drug used to treat abnormal blood pressure and should only be taken under the supervision of a healthcare professional.
  • Hydroxyhomothiosildenafil is an unauthorized substance similar to sildenafil, a prescription drug used to treat erectile dysfunction, and my pose similar health risks. Sildenafil should only be taken under the supervision of a healthcare professional.

Place of origin

Unknown

Side effects

Side effects associated with yohimbine include abnormal blood pressure and heartbeat, anxiety, tremors, headache, nausea and sleep disorders.
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.

Rhino 5 Plus, Maxtremezen, and Extenzone

Product description

These products are promoted for sexual enhancement.

The affected products are Lot KWAKPMC030505175957019 for the product Rhino 5 Plus, Lot JBP-L-1270-70 for the product Maxtremezen, and Lot KWAKPMC03050517 for the product Extenzone.

Hazard identified

The United States Food and Drug Administration warned consumers not to use these products after they were found to contain desmethylcarbondenafil and dapoxetine.

  • Desmethylcarbondenafil is an unauthorized substance that may be similar to prescription drugs used to treat erectile dysfunction and may pose similar health risks. Prescription drugs should only be taken under the supervision of a health care professional.
  • Dapoxetine is a prescription drug used to treat premature ejaculation and is not authorized for sale in Canada.

Place of origin

Jobbers Wholesale (Paramount CA)

Side effects

Erectile dysfunction drugs 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.

Side effects associated with dapoxetine include seizures, changes in blood pressure, blurred vision, dizziness, headache and nausea.

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 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 August 8, 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

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