Foreign Product Alert: 15 Health Products

Starting date:
July 4, 2016
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information, Unauthorized products, Contamination
Audience:
General Public
Identification number:
RA-59048

Issue

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients or high levels of heavy metals that may pose serious health risks.

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 Product
Product Name(s) Hazard(s) Identified Source of Alert Other product information, if available Images
Unauthorized Weight Loss Products
Dynamizm Capsules Undeclared sibutramine United States Food and Drug Administration  
ENVY BP Undeclared sibutramine United States Food and Drug Administration  
Eradicate Capsules Undeclared sibutramine  and desmethylsibutramine United States Food and Drug Administration  
Leisure Slimming capsules Undeclared sibutramine and phenolphthalein Australian Therapeutic Goods Administration  
Propell Platinum Undeclared sibutramine United States Food and Drug Administration  
U Slimming and U Plus Slimming capsules Undeclared sibutramine, phenolphthalein, diclofenac, and lignocaine Australian Therapeutic Goods Administration  
Xerophagy Capsules Undeclared sibutramine United States Food and Drug Administration  
Unauthorized Sexual Enhancement Products
MMC Zang Ba Bao tablets Undeclared sildenafil Australian Therapeutic Goods Administration  
Salute Capsules Undeclared sildenafil, thiosildenafil, and sulfoaildenafil  United States Food and Drug Administration  
Sextra Undeclared sildenafil United States Food and Drug Administration  
Super Bull 6000 Herbal capsules Undeclared sildenafil Australian Therapeutic Goods Administration  
U.S. Black Gold tablets Undeclared sildenafil Australian Therapeutic Goods Administration  
Zlimxter Capsules Undeclared sildenafil United States Food and Drug Administration  
Other Unauthorized Products
Best Bentonite Clay Elevated levels of lead United States Food and Drug Administration  

What you should do

  • Contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find a product listed above in the Canadian marketplace.
  • Consult with 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 a Homeopathic Drug Number (DIN-HM).

Background

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

Desmethylsibutramine is an unauthorized substance similar to sibutramine, a prescription drug used to treat obesity and may pose similar health risks. 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.

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.

Lead is a heavy metal that poses serious health risks because it may accumulate in vital organs of the body. Children are most susceptible to the toxic effects of heavy metals. The toxic effects of lead include abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage.

Lignocaine, also known as lidocaine, is a drug that is available with or without a prescription. It can be used as a local numbing agent or it can be injected intravenously to treat abnormal heart rhythms (beats).  Serious side effects include abnormal heartbeat, low blood pressure, breathing problems, agitation, confusion, seizure, and coma.

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 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.

Sulfoaildenafil is an unauthorized substance similar to sildenafil, a prescription drug used to treat erectile dysfunction and may pose similar health risks.  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.

Thiosildenafil is an unauthorized substance similar to sildenafil, a prescription drug used to treat erectile dysfunction and may pose similar health risks.  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.

Report health or safety concerns

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 June 17, 2016, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

Select thumbnail to enlarge - opens in a new window