Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max+ capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Ext...
- Starting date:
- November 22, 2018
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-68358
Issue
These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).
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.
| Product Name(s) | Hazard(s) Identified | Source of Alert | Images |
|---|---|---|---|
| Unauthorized Sexual Enhancement Products | |||
| Black Lion Pill | Undeclared sildenafil | United States Food and Drug Administration |
|
| Horny Little Devil | Undeclared sildenafil and tadalafil | European Commission |
|
| Papapa | Undeclared tadalafil, hydroxyhomosildenafil | Hong Kong Department of Health |
|
| Red Zone Xtreme 3000 capsules | Undeclared tadalafil | United States Food and Drug Administration |
|
| Rhino 69 Extreme 50000 capsules | Undeclared tadalafil | United States Food and Drug Administration |
|
| Unauthorized Weight Loss Products | |||
| Help 100% & Pure Natural & Body Slim capsules | Undeclared sibutramine | Australia Therapeutic Goods Administration |
|
| Ja Dera Max+ capsules | Undeclared lidocaine | Australia Therapeutic Goods Administration |
|
| Lida (Plus) capsules | Undeclared sibutramine and phenolphthalein | Australia Therapeutic Goods Administration |
|
| Nutra Organics Green Tea Extract capsules | Undeclared sibutramine | Australia Therapeutic Goods Administration |
|
| Slim Trim Gold capsules | Undeclared sibutramine and phenolphthalein | Australia Therapeutic Goods Administration |
|
| Other Unauthorized Products | |||
| Herba Saraf capsules | Undeclared dexamethasone | Singapore Health Sciences Authority |
|
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.
Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Side effects include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders. Consult with your healthcare professional prior to stopping use, as sudden discontinuation of dexamethasone may cause symptoms of withdrawal.
Lidocaine is a local anesthetic (numbing medication) that should not be ingested (swallowed). Risks of ingesting this drug include difficulty swallowing or breathing, drowsiness, allergic reaction, and irregular heartbeat.
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.
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.
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 February 12, 2018 no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.
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