Foreign Product Alert: Big N Hard, Black Gorilla, Cummor, Dragon Max, Oh Baby!, Man XXX, Maxman IV, Maxman Premium, Maxman V, Monkey Business, MMC Maxman XI, MME Maxman IX capsules, New Advanced Technological, V9 Male Sexual Stimulant, Real Skill Male Sexual Stimulant, Rize N Shine, Tornado, Xrect, XXXL Penis Enlarging Ointment, Z Daily

Starting date:
July 25, 2017
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information, Undeclared Substance, Unauthorized products
Audience:
General Public
Identification number:
RA-64052

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 however, 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
Big N Hard Undeclared tadalafil United States Food and Drug Administration
Black Gorilla Undeclared sildenafil Australia Therapeutic Goods Administration
Cummor Undeclared N-desmethyl tadalafil United States Food and Drug Administration
Dragon Max Undeclared tadalafil Australia Therapeutic Goods Administration
Oh Baby! Undeclared tadalafil Australia Therapeutic Goods Administration
Man XXX Undeclared levodopa Australia Therapeutic Goods Administration
Maxman IV Undeclared sildenafil Australia Therapeutic Goods Administration
Maxman Premium Undeclared sildenafil Australia Therapeutic Goods Administration
Maxman V Undeclared sildenafil Australia Therapeutic Goods Administration
Monkey Business Undeclared N-desmethyl tadalafil United States Food and Drug Administration
MMC Maxman XI Undeclared sildenafil Australia Therapeutic Goods Administration
MME Maxman IX Undeclared sildenafil Australia Therapeutic Goods Administration
New Advanced Technological Undeclared sildenafil Australia Therapeutic Goods Administration
V9 Male Sexual Stimulant Undeclared sildenafil Australia Therapeutic Goods Administration
Real Skill Male Sexual Stimulant Undeclared sildenafil Australia Therapeutic Goods Administration
Rize N Shine Undeclared sildenafil Australia Therapeutic Goods Administration
Tornado Undeclared nortadalafil United States Food and Drug Administration
Xrect Undeclared tadalafil and descarbonsildenafil United States Food and Drug Administration
XXXL Penis Enlarging Ointment Undeclared tadalafil Australia Therapeutic Goods Administration
Z Daily Undeclared homosildenafil United States Food and Drug 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.

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) 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 (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.

Descarbonsildenafil is an unauthorized substance similar to sildenafil, a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Homosildenafil is an unauthorized substance similar to sildenafil, a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Levodopa is a prescription drug used to treat Parkinson's disease. Levodopa should not be used by women who are pregnant, who plan to become pregnant or who are breastfeeding. It should also not be taken by people with narrow angle glaucoma; untreated heart, liver, kidney, lung or hormonal diseases; a history of melanoma; or those who should not take drugs such as isoproterenol, amphetamines or epinephrine. Side effects include uncontrollable movements of the face, eyelids, mouth, tongue, neck, arms, hands or legs; severe or persistent nausea or vomiting; an irregular heartbeat or fluttering in the chest; feeling lightheaded when standing quickly; or unusual changes in mood or behaviour.

N-desmethyl tadalafil is an unauthorized substance similar to tadalafil, a prescription drug used to treat erectile dysfunction. 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.

Nortadalafil is an unauthorized substance similar to tadalafil, a prescription drug used to treat erectile dysfunction. 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.

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.

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