Foreign Product Alert: JOYSMI, Magnum XXL capsules, Meizitang Botanical Slimming soft gels, Make Coarser Make Bigger, X Power 3 tablets

Starting date:
June 28, 2019
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-70317

Last updated:

These foreign health products have been found by the Australian Therapeutic Goods Administration to contain undeclared drug ingredients.

The 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.

Unauthorized Foreign Health Products
Product Name(s) Hazard(s) Identified Source of Alert Images

Unauthorized Sexual Enhancement Products

Magnum XXL capsules

Undeclared tadalafil

Australia Therapeutic Goods Administration

Make Coarser Make Bigger

Undeclared 2-mercaptobenzothiazole, diclofenac and glibenclamide

Australia Therapeutic Goods Administration

X Power 3 tablets

Undeclared sildenafil

Australia Therapeutic Goods Administration

Unauthorized Weight Loss Products

Meizitang Botanical Slimming soft gels

Undeclared sildenafil and sildenafil N-oxide

Australia Therapeutic Goods Administration

Other Unauthorized Products

JOYSMI

Undeclared sibutramine, phenolphthalein, and frusemide

Australia Therapeutic Goods Administration

 

What you should do

  • Contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a product listed above in the Canadian marketplace.
  • Consult a healthcare professional if you have health concerns related to the use of any of these products.
  • Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM).

Background

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

Diclofenac is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Side effects include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.

Frusemide (furosemide) is a diuretic (water pill) prescription drug used to remove excess fluid from the body. Side effects include changes in electrolytes (specifically potassium), muscle cramps, dizziness, low blood pressure, headache and nausea.

Glibenclamide (also known as glyburide) is a prescription drug used to treat diabetes. Side effects include severely low blood sugar, which may cause sweating, paleness, chills, headache, dizziness and confusion.

2-mercaptobenzothiazole is a chemical that is mainly used in the manufacture of rubber products and has no known therapeutic use in humans. Exposure to 2-mercaptobenzothiazole has been shown to cause cancer in animals. Occupational exposure to 2-mercaptobenzothiazole may cause allergic contact dermatitis (rash) in humans.

Phenolphthalein was previously used as a laxative, but is no longer authorized for sale in Canada because it may cause cancer. Additional side effects include decreased blood pressure, skin rash and gastrointestinal bleeding.

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. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil, including related substances like sildenafil nitric oxide (sildenafil N-oxide), should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerin) 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.

Tadalafil is a prescription drug used to treat erectile dysfunction. 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.

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

As of April 29, 2019, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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