Unauthorized products may pose serious health risks (December 10, 2018 to April 17, 2019)

Starting date:
December 10, 2018
Posting date:
April 17, 2019
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-68576

Last updated:

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. Links to previous tables with affected products are also available below.

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.

Background

Cardarine (also known as GW501516 and possibly GW1516), MK-677 and SR-9009 are not authorized in Canada for any use and may pose serious health risks. All clinical development of GW501516 was stopped when toxicities, including various cancers, were discovered following routine, long-term animal studies. The long-term effects in humans are unknown.

Dimethylamylamine (DMAA) is a drug that is not authorized for use in Canada. Side effects include high blood pressure, shortness of breath, chest pain, stroke and psychiatric disorders.

"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 healthcare 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.

Rauwolfia (also known as rauvolfia) is a prescription drug that can be used to treat high blood pressure (hypertension). People with heart conditions or psychiatric disorders should receive close medical supervision when using it as it can make certain conditions, such as depression, worse. Common side effects include tiredness, sleepiness, depression, nasal obstruction and breathlessness. Rauwolfia should not be used by children, or pregnant or nursing women.

Selective Androgen Receptor Modulators (SARMs) are drugs that are not authorized in Canada for any use and have not been reviewed by Health Canada for safety, effectiveness and quality. The use of bodybuilding products that contain SARMs can pose serious health risks such as heart attack, stroke and liver damage. The long-term effects on the body are unknown. Examples include andarine, ostarine, LDG-4033, YK-11, and RAD-140.

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.

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.

Affected products

See table here. Links to previous tables with affected products are also available below.

Product description

Unauthorized health products
Photo Product &
Promoted Use
Hazard Identified Company Action Taken Date Added
777 k 777 K
Sexual enhancement
Labelled to contain yohimbe 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
Extreme diamond 2000 Extreme Diamond 2000
Sexual enhancement
Product with similar packaging previously seized from other retailers was tested and found to contain sildenafil 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
Green Mamba Green Mamba
Sexual enhancement
Labelled to contain yohimbe 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
LipsTenZen LipsTenZen
Sexual enhancement
Labelled to contain yohimbe 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
Passion Classic Maximum Power Passion Classic Maximum Power
Sexual enhancement
Labelled to contain yohimbe 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
Red Lips Premium Triple Maximum Red Lips Premium Triple Maximum
Sexual enhancement
Labelled to contain yohimbe 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
rush Rush
Poppers
Labelled to contain isobutyl nitrite (an alkyl nitrite) 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
The Original Jungle Juice Platinum The Original Jungle Juice Platinum
Poppers
Labelled to contain isobutyl nitrite (an alkyl nitrite) 24 Hour Mart
Units 536, 538 & 540 Yonge Street
Toronto, ON
Seized from the retail location April 17, 2019
titanuum Titanium 4000
Sexual enhancement
Product tested by Health Canada and found to contain sildenafil and tadalafil Adult Source #102-2323 32 Ave NE, Calgary, AB Seized from the retail location March 20, 2019
iron horse 10K Iron Horse
Sexual enhancement
Product tested by Health Canada and found to contain tadalafil

Adult Source

Locations:

#102-2323 32 Ave NE, Calgary, AB
4310 17 Ave SE, Calgary, AB
10210 Macleod Trail SE, Calgary, AB

Seized from the retail location March 20, 2019
sarm center sarm center
Andarine
Workout supplement
Labelled to contain andarine Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm center
GW-1516
Workout supplement
Labelled to contain GW-1516 Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm center
MK-677
Workout supplement
Labelled to contain MK-677 Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm center
Ostarine
Workout supplement
Labelled to contain ostarine Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm center
RAD-140
Workout supplement
Labelled to contain RAD-140 Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm center
SR-9009 (liquid)
Workout supplement
Labelled to contain SR-9009 Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm sc
SR-9009 (capsules)
Workout supplement
Labelled to contain SR-9009 Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
sarm center sarm center
YK-11
Workout supplement
Labelled to
contain YK-11
Fitness City Supplements
2101 Trans-Canada Route
Dorval, QC
Seized from the retail location March 15, 2019
Dust Extreme Dust Extreme
Workout supplement
Labelled to contain 1,3 DMAA (Dimethylamylamine) Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
Insane Labz Insane Labz
I AM GOD
Workout supplement
Labelled to contain rauwolfia Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
GW-1516
Workout supplement
Labelled to contain GW-1516 Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
LGD-4033
Workout supplement
Labelled to contain LGD-4033 Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
MK-677
Workout supplement
Labelled to contain MK-677 Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
RAD-140
Workout supplement
Labelled to contain RAD-140 Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
Ostarine
Workout supplement
Labelled to contain ostarine Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
Andarine
Workout supplement
Labelled to contain andarine Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
sarm center sarm center
SR-9009
Workout supplement
Labelled to contain SR-9009 Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
Sidewalk Kraka Sidewalk Kraka
Workout supplement
Labelled to contain rauwolfia Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018
Stimul-8 Stimul-8
Workout supplement
Labelled to contain rauwolfia Atomik Nutrition Brossard
8025 Taschereau Local G
Brossard, QC
Seized from the retail location December 10, 2018


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