Foreign Product Alert: CA NI Slim BELLANCE, Chao Jimengnan Super Powerful Man, Goldreallas Original, Goldreallas XXX, Impeous Man, Lean Extreme Max, Old Chinese, Platinum Max Strength Blue Pill Version, Platinum Weight Loss Solution, Shenjingpian, Slimming Plus Advanced, XtraHRD, X-treme Beauty Slim, Zhen Gongfu

Starting date:
March 28, 2017
Posting date:
March 28, 2017
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs, Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products, Undeclared Substance, Important Safety Information
Identification number:
RA-62814

Issue

These foreign health products have been found by regulators in other countries 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
Chao Jimengnan Super Powerful Man Tablets Undeclared sildenafil Australian Therapeutic Goods Administration Chao Jimengnan Super Powerful Man Tablets
GoldReallas Original Undeclared sildenafil and  thiosildenafil United States Food and Drug Administration GoldReallas Original
GoldReallas XXX Undeclared sildenafil and thiosildenafil United States Food and Drug Administration GoldReallas XXX
Impeous Man capsules Undeclared sildenafil and phenolphthalein Australian Therapeutic Goods Administration Impeous Man capsules
Old Chinese Undeclared sildenafil United States Food and Drug Administration Old Chinese
Shenjingpian Undeclared sildenafil United States Food and Drug Administration Shenjingpian
XtraHRD Undeclared  
N-desmethyl tadalafil
United States Food and Drug Administration XtraHRD
Zhen Gongfu capsules Undeclared sildenafil Australian Therapeutic Goods Administration Zhen Gongfu capsules
Unauthorized Weight Loss Products
CA NI Slim BELLANCE Undeclared orlistat Hong Kong  Department of Health CA NI Slim BELLANCE
Lean Extreme Max Undeclared sibutramine United States Food and Drug Administration Lean Extreme Max
Platinum Max Strength Blue Pill Version Undeclared sibutramine and phenolphthalein United States Food and Drug Administration Platinum Max Strength Blue Pill Version
Platinum Weight Loss Solution Undeclared sibutramine and phenolpthalein United States Food and Drug Administration Platinum Weight Loss Solution
Slimming Plus Advanced Undeclared sibutramine and phenolphthalein United States Food and Drug Administration Slimming Plus Advanced
X-treme Beauty Slim Undeclared sibutramine United States Food and Drug Administration X-treme Beauty Slim

 

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 be used only under the supervision of a healthcare professional.

N-desmethyl tadalafil is an unauthorized substance similar to tadalafil, a prescription drug used to treat erectile dysfunction. N-desmethyl tadalafil may pose similar health risks as tadalafil. Tadalafil should not be used by individuals taking any kind of nitrate drug (such as 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.

Orlistat is a prescription weight-loss drug. Side effects include abdominal discomfort, anal leakage, increased stool volume and frequency, and fatty or oily stool.

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 (such as nitroglycerine) because 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 (such as nitroglycerine) because 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 March 3, 2017, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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