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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 Mal...
- 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.
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.
Images
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