Foreign Product Alert: Adipessum Miracle Slimming Capsules, Beautiful Lose Weight, Blue Pearl All Natural Male Enhancement pill, Chong Cao Dan pills, Fruta Planta Life capsules, Hard Rod Plus capsules, Hard Times for Men capsule, Linsen Double Caulis...

Starting date:: January 17, 2018
Type of communication:: Foreign Product Alert (FPA)
Subcategory:: Natural health products
Source of recall:: Health Canada
Identification number:: RA-65734

Issue
What you should do
Background
Report health or safety concerns
Images

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
Unauthorized Sexual Enhancement Products
Blue Pearl All Natural Male Enhancement pill	Undeclared sildenafil	United States Food and Drug Administration
Hard Rod Plus capsules	Undeclared aminotadalafil	Australia Therapeutic Goods Administration
Hard Times for Men capsule	Undeclared sildenafil	United States Food and Drug Administration
Red Ant	Undeclared sildenafil	Australia Therapeutic Goods Administration
Super Soniic capsules	Undeclared strychnine and sildenafil	Australia Therapeutic Goods Administration
Unauthorized Weight Loss Products
Adipessum Miracle Slimming capsules	Undeclared fluoxetine	United States Food and Drug Administration
Beautiful Lose Weight	Undeclared sibutramine and phenolphthalein	Australia Therapeutic Goods Administration
Fruta Planta Life capsules	Undeclared sibutramine	United States Food and Drug Administration
Lishou Fuling Jiaonang	Undeclared sibutramine	Australia Therapeutic Goods Administration
Lose Weight 30	Undeclared sibutramine	Australia Therapeutic Goods Administration
Other Unauthorized Products
Chong Cao Dan pills	Undeclared dexamethasone, chlorpheniramine, and frusemide (furosemide)	Singapore Health Sciences Authority
Linsen Double Caulis Plus capsules	Undeclared dexamethasone	United States Food and Drug Administration
Wan Ling Ren Sem Chin Kuo pills	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.

Aminotadalafil is an unauthorized substance similar to tadalafil, a prescription drug used to treat erectile dysfunction. Aminotadalafil may pose similar health risks as tadalafil. 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.

Chlorpheniramine is a non-prescription antihistamine drug. Side-effects include drowsiness, dizziness, confusion, and blurred vision.

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 ulcers; blood disorders; skin, muscle and bone damage; and nervous system disorders. Consult with your healthcare professional before you stop using dexamethasone, since you may have withdrawal symptoms if you suddenly stop using it.

Fluoxetine is a prescription drug used to treat depression. Side effects include headache, sleeping problems, anxiety, nausea, loss of appetite, and excessive sweating.

Frusemide (Furosemide) is a diuretic (water pill) prescription drug used to remove excess fluid from the body. Side effects include changes in electrolytes (specifically potassium), muscle cramps, dizziness, low blood pressure, headache, and nausea.

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.

Strychnine is a substance derived from the seeds of Strychnos or Loganiaceae plants, and may be found in some authorized natural health products at low doses. At higher doses, strychnine is highly poisonous. Symptoms of strychnine poisoning appear 15 to 60 minutes after ingesting the substance and include painful muscle spasms, rigid arms and legs, jaw tightness, difficulty breathing, and agitation. In some cases, strychnine poisoning may lead to death.

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 November 30, 2017, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.