Thirteen unauthorized products seized at various Ontario retailers may pose serious health risks

Starting date:

March 23, 2016

Posting date:

March 23, 2016

Type of communication:

Advisory

Subcategory:

Drugs, Chemicals

Source of recall:

Health Canada

Issue:

Important Safety Information, Product Safety

Audience:

General Public

Identification number:

RA-57642

• 
  Issue
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Products affected

Retailer	Product name	Ingredient	Indication	Photo
One in Ten, 256 Bank St., Ottawa	Ejaculoid	Yohimbine	sexual enhancement
One in Ten, 256 Bank St., Ottawa	RSE7EN	Desmethyl carbodenafil & dapoxetine	sexual enhancement
One in Ten, 256 Bank St., Ottawa	Extreme Diamond 2000	Desmethyl carbodenafil	sexual enhancement
One in Ten, 256 Bank St., Ottawa	Master Zone 1500	Sildenafil & tadalafil	sexual enhancement
One in Ten, 256 Bank St., Ottawa	Black Magic	Sildenafil	sexual enhancement
One in Ten, 256 Bank St., Ottawa	Rock Hard Weekend	Sildenafil	sexual enhancement
One in Ten, 256 Bank St., Ottawa	MV7 days 3500	Sildenafil & tadalafil	sexual enhancement
One in Ten, 256 Bank St., Ottawa	MV7 days 2000	Sildenafil & tadalafil	sexual enhancement
One in Ten, 256 Bank St., Ottawa	Black Panther	Sildenafil & desmethyl carbodenafil & dapoxetine	sexual enhancement
One in Ten, 256 Bank St., Ottawa & Private Pleasures, 5126 Dundas Street West, Etobocoke	Mamba is Hero	Sildenafil & dimethyl carbodenafil & dapoxetine	sexual enhancement
One in Ten, 256 Bank St., Ottawa	Black Mamba premium	Desmethyl carbodenafil & dapoxetine	sexual enhancement
BOSS Supplements, 411 Bayfield St., Barrie	Animal Test	Yohimbine	Dietary supplements
Flex Plex, 1700 Dundas St. E, London	Dust V2	Yohimbine	Dietary supplements

Issue

Health Canada seized thirteen unauthorized drugs promoted for sexual enhancement or as bodybuilding supplements from four separate retailers in Ontario (see table below). The products were found to contain or were labelled to contain various prescription drug substances and other drug substances that may pose serious risks to the health of Canadians.

What you should do

• Consult with your health-care professional if you have used any of these products and have health concerns.
• Read the product label. Health products that  have been authorized for sale by Health Canada have an eight-digit DIN, a DIN-HM or a NPN.
• Verify that your health products have been authorized for sale by searching the Drug Product Database, Medical Devices Active Licence Listing (MDALL) and the Licensed Natural Health Product Database.
• Report any adverse events to Health Canada
• Report complaints about health products to Health Canada by calling toll-free to 1-800-267-9675, or complete an online complaint form.

Who is affected

Consumers who have purchased or used any of these products, particularly those with heart conditions.

Background

Sildenafil and tadalafil are prescription drug ingredients. Products containing these ingredients should only be used under the supervision of a health-care practitioner. Sildenafil and 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.

Desmethyl carbondenafil is a substance similar to sildenafil and may pose similar health risks.

Dapoxetine is a drug ingredient. Side effects include seizures, changes in blood pressure, blurred vision, dizziness, headache and nausea.

Yohimbine is a prescription drug ingredient. Products containing yohimbine should only be used under the supervision of a health-care practitioner. The use of drugs containing yohimbine (either as yohimbine hydrochloride or yohimbe bark extract) may result in serious adverse reactions, particularly in people with high blood pressure, or heart, kidney or liver disease. Side effects associated with yohimbine include increased blood pressure and heart rate, anxiety, dizziness, tremors, headache, nausea and sleep disorders. It should not be used by children, pregnant women or nursing women.

Report health or safety concerns

• Call Health Canada toll-free at 1-866-234-2345.
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using
social media tools.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Health Canada has seized the products from the retail locations. Should additional retailers or distributors of these products be identified, Health Canada will take appropriate action and inform Canadians.

Images

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