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Foreign Product Alert: Excellence Losing Weight capsules, Meizitang Botanical Slimming 100% Natural Soft Gel, Natural Model capsules, Boss Number #Six, Bull, Bull's Genital, Ginseng Power-X, Golden Night, Half Quite tablets, Maxagra capsules, Neophase Natural Sex Enhancer, Ninja-X, Sextra capsules, Weekend Prince, Wonder-Erect Male Gum, Amazon Tonic III, Bentonite Me Baby, Crema Piel de Seda, Licorice Coughing Liquid, Zhong Hua Niu Bian tablets

Starting date:
June 14, 2016
Posting date:
June 14, 2016
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-58884

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients, toxic substances or high levels of heavy metals, which 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.

Issue

Unauthorized foreign health products
Product Name(s) Hazard(s) Identified Source of Alert Other product information, if available Images
Unauthorized Weight Loss Products
Excellence Losing Weight capsules Undeclared sibutramine Australian Therapeutic Goods Administration  
Meizitang Botanical Slimming 100% Natural Soft Gel Undeclared diclofenac Singapore Health Sciences Authority  
Natural Model capsules Undeclared sibutramine and phenolphthalein Australian Therapeutic Goods Administration  
Unauthorized Sexual Enhancement Products
Boss Number #Six Undeclared tadalafil United States Food and Drug Administration  
Bull Undeclared sildenafil United States Food and Drug Administration  
Bull's Genital Undeclared sildenafil United States Food and Drug Administration  
Ginseng Power-X Undeclared sildenafil and sulfoaildenafil United States Food and Drug Administration  
Golden Night Undeclared sildenafil and hydroxythiohomosildenafil United States Food and Drug Administration  
Half Quite tablets Undeclared sildenafil Australian Therapeutic Goods Administration  
Maxagra capsules Undeclared sildenafil and oxytetracycline Australian Therapeutic Goods Administration  
Neophase Natural Sex Enhancer Undeclared hydroxyacetildenafil United States Food and Drug Administration  
Ninja-X Undeclared sildenafil and thiosildenafil United States Food and Drug Administration  
Sextra capsules Undeclared sildenafil and yohimbine Australian Therapeutic Goods Administration  
Weekend Prince Undeclared sildenafil United States Food and Drug Administration  
Wonder-Erect Male Gum Undeclared vardenafil United States Food and Drug Administration  
Other Unauthorized Products
Amazon Tonic III Undeclared oleandrin

Also, product is promoted as a cancer treatment. There is no evidence that it can treat cancer.
Australian Therapeutic Goods Administration  
Bentonite Me Baby Elevated levels of lead United States Food and Drug Administration  
Crema Piel de Seda Elevated levels of mercury United States Food and Drug Administration  
Licorice Coughing Liquid Undeclared morphine United States Food and Drug Administration  
Zhong Hua Niu Bian tablets Undeclared chloramphenicol and sildenafil Australian Therapeutic Goods 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.

Chloramphenicol is a prescription antibiotic drug.  Side effects associated with chloramphenicol include abdominal pain, allergic reactions, and bone marrow failure (aplastic anemia).

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.

Hydroxyacetildenafil 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.

Hydroxythiohomosildenafil 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.

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.

Mercury 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 mercury include irritability, tremors, memory loss, insomnia, concentration problems, and kidney and brain damage.

Morphine is a narcotic used to treat pain.  Side effects associated with morphine include drowsiness, dizziness, confusion, slow breathing, coma, and death.

Oleandrin is a toxic substance at high doses.  Side effects associated with oleandrin include nausea, abdominal pain, vomiting and diarrhea, heart rhythm problems, drowsiness, tremors, seizure, and coma. 

Oxytetracycline is a prescription antibiotic drug.  Side effects associated with oxytetracycline include abdominal pain, nausea, vomiting, diarrhea, light-headedness, dizziness, and ringing in the ears (tinnitus).  Other side effects include red rash on sun-exposed skins and liver and kidney injuries.  Oxytetracycline is also associated with permanent teeth discolouration and delayed bone growth in young children.

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.

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.

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.

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

Yohimbine is a prescription drug used to treat abnormal blood pressure and should only be taken under the supervision of a healthcare professional.  Side effects associated with yohimbine include abnormal blood pressure and heartbeat, anxiety, tremors, headache, nausea and sleep disorders.

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 3, 2016, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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