Unauthorized products may pose serious health risks

Starting date:
November 17, 2017
Posting date:
December 14, 2017
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-65132

Issue

Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. The table below is updated when Health Canada finds unauthorized health products that are promoted for sexual enhancement, weight loss, as a workout aid, or as “poppers,” and that are labelled to contain or have been tested and found to contain dangerous ingredients.

Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality. Unauthorized health products can pose many health dangers, including:

  • They may contain ingredients not listed on the label. This includes ingredients like prescription drugs, possibly at doses exceeding maximum recommended amounts. Prescription drugs should be taken only under the supervision of a health professional because they may cause serious side effects. Using a product that contains ingredients that the consumer is not aware of increases the chance of dangerous allergies and interactions with other medications and foods.
  • The label may indicate a dangerous ingredient or combination of ingredients. For example, it could list a drug that should be available only by prescription from a heath care professional, or a combination of ingredients that Health Canada does not permit because of serious health risks.

Health Canada maintains this page so that Canadians can easily identify products they may have purchased and take appropriate action. Canadians are encouraged to check back regularly for updates. Advisories on safety issues involving other types of products are available in the recalls and safety alerts database.

What you should do

  • Stop using the products listed below. Consult your health care professional if you have used these products and have health concerns, and for advice on which health products are best for you and your family.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check if products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.
  • Report any health product adverse events or complaints to Health Canada.
  • See the additional information on buying health products safely in the helpful links below.

What companies should know:

  • Selling unauthorized health products in Canada is illegal.
  • When Health Canada identifies unauthorized products that may pose serious health risks, Health Canada takes appropriate action to prevent further distribution and informs Canadians. This includes working with the Canada Border Services Agency to help prevent further importation of unauthorized products.

Affected products

See table below.

Product description

Unauthorized health products
Photo Product &
Promoted Use
Hazard Identified Company Action Taken Date Added

7K
Sexual enhancement

Labelled to contain yohimbe

 

 

Adult Source

Locations:
#102, 2323-32 Avenue NE
Calgary, AB

1540 16 Ave NW, Calgary, AB

4310 17 Ave SE, Calgary, AB

10210 Macleod Trail SE, Calgary, AB

Seized  by Health Canada

December 14, 2017

LipsTenZen
Sexual enhancement

Labelled to contain yohimbe

Adult Source

Locations:
#102, 2323-32 Avenue NE
Calgary, AB

1540 16 Ave NW, Calgary, AB

4310 17 Ave SE, Calgary, AB

10210 Macleod Trail SE, Calgary, AB

Seized by Health Canada

December 14, 2017

Rush
Popper

Product with similar packaging previously seized from other retailers was labelled to contain an alkyl nitrite

Adult Source

Locations:
#102, 2323-32 Avenue NE
Calgary, AB

1540 16 Ave NW
Calgary, AB

4310 17 Ave SE, Calgary, AB

10210 Macleod Trail SE, Calgary, AB

Seized by Health Canada

December 14, 2017

Stiff 4 Hours
Sexual enhancement

Product with similar packaging previously seized from other retailers was tested and found to contain sildenafil

Adult Source

Locations:
#102, 2323-32 Avenue NE
Calgary, AB

1540 16 Ave NW, Calgary, AB

4310 17 Ave SE, Calgary, AB

10210 Macleod Trail SE, Calgary, AB

Seized by Health Canada

December 14, 2017

Titanium 4000
Sexual enhancement

Product with similar packaging previously seized from other retailers was tested and found to contain sildenafil and tadalafil

Adult Source

Locations:
#102, 2323-32 Avenue NE
Calgary, AB

1540 16 Ave NW, Calgary, AB

4310 17 Ave SE, Calgary, AB

10210 Macleod Trail SE, Calgary, AB

Seized by Health Canada

December 14, 2017

Black Mamba 2 Premium
Sexual enhancement
Labelled to contain yohimbe KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Japan Tengsu
Sexual enhancement
Labelled to contain sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
USA Black Gold
Sexual enhancement
Labelled to contain sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Zhen Gongfu
Sexual enhancement
Product with similar packaging previously seized from other retailers was tested and found to contain sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Bl4ck 4K
Sexual enhancement
Product with similar packaging previously seized from other retailers was tested and found to contain sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Black Storm
Sexual enhancement
Product with similar packaging tested by the Australian Therapeutic Goods Administration was found to contain undeclared sildenafil and vardenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Vigour 800
Sexual enhancement
Product with similar packaging tested by the Australian Therapeutic Goods Administration was found to contain undeclared sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Super Bull 6000
Sexual enhancement
Product with similar packaging tested by the Australian Therapeutic Goods Administration was found to contain undeclared sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Africa Black Ant
Sexual enhancement
Product with similar packaging tested by the Australian Therapeutic Goods Administration was found to contain undeclared sildenafil KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Germany Niubian
Sexual enhancement
Product with similar packaging tested by the Australian Therapeutic Goods Administration was found to contain undeclared sildenafil and zopiclone KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Rhino 7K 9000
Sexual enhancement
Product with similar packaging tested by the United States Food and Drug Administration
was found to contain undeclared sildenafil
KW Import & Wholesale
1031 Victoria St. N, Kitchener, ON
Seized from the retail location November 17, 2017
Black Mamba 2 Premium
Sexual enhancement
Labelled to contain yohimbe Rearz Inc.
656 Colby Drive, Waterloo, ON
Seized from the retail location November 17, 2017
Hard Ten Days
Sexual enhancement
Product with similar packaging tested by the United States Food and Drug Administration
was found to contain undeclared sildenafil
Rearz Inc.
656 Colby Drive, Waterloo, ON
Seized from the retail location November 17, 2017
Zhen Gongfu
Sexual enhancement
Product with similar packaging previously seized from other retailers was tested and found to contain sildenafil Rearz Inc.
656 Colby Drive, Waterloo, ON
Seized from the retail location November 17, 2017

Background

"Poppers" is a slang term for products that contain alkyl nitrites. Despite being labelled for various uses such as leather cleaners, room odourizers or liquid incense, these products are inhaled or ingested by consumers for recreational purposes. Alkyl nitrites, such as amyl nitrite, butyl nitrite and isobutyl nitrite, are prescription drugs and should be used only under the supervision of a health care professional. Products containing alkyl nitrites may pose serious risks, including death, depending on the amount used, how frequently they are used and how long they are used for, as well as the person's health and the other medications they may be taking. Since it is difficult to control how much is inhaled, people can accidentally overdose. Swallowing these products can lead to serious medical complications and may be fatal. People with certain medical conditions (including recent head trauma, bleeding into the head, glaucoma, or heart disease) and those taking certain medications (particularly drugs used to treat erectile dysfunction, and other drugs such as high blood pressure medications, certain migraine drugs, and high doses of aspirin) or illicit drugs are at particular risk.

Sildenafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It 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 possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Tadalafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It 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 possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Vardenafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It 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 possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Yohimbine is a prescription drug and should be used only under the supervision of a health care professional. Yohimbine is derived from yohimbe, a bark extract. The use of yohimbine or yohimbe may result in serious adverse reactions, particularly in people with high blood pressure, or heart, kidney or liver disease. Side effects include increased blood pressure and heart rate, anxiety, dizziness, tremors, headache, nausea and sleep disorders. It should not be used by children, or pregnant or nursing women.

Zopiclone is a prescription drug used to treat insomnia. Side effects associated with zopiclone include unpleasant taste, drowsiness, dizziness, memory loss and hallucinations.


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