Foreign Product Alerts: Wood-E, Xzen Gold, Xzen XPress, XZen 1200, and XZone Premium

Starting date:
May 28, 2014
Posting date:
May 28, 2014
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs
Source of recall:
Health Canada
Source of alert:

US FDA

Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-39631

Introduction

These 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.

Affected products

  • Wood-E
  • Xzen Gold
  • XZen 1200
  • XZen XPress
  • XZone Premium

Wood-E, Xzen Gold, Xzen XPress, and XZen 1200

Product description

These products are promoted for sexual enhancement.

Hazard identified

The United States Food and Drug Administration (US FDA) warned consumers not to use these products after they were found to contain drug ingredients that were not declared on the label.

  • Wood-E contains sildenafil
  • Xzen Gold and Xzen XPress contain sildenafil and tadalafil
  • XZen 1200 contains tadalafil

Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction. They should only be taken under the supervision of a healthcare professional.

Place of origin

Unknown.

Side effects

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.

In addition, 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.

X Zone Premium

Product description

This product is promoted for sexual enhancement.

Hazard identified

The US FDA warned consumers not to use this product after it was found to contain undeclared sildenafil, tadalafil and dapoxetine.

Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction. They should only be taken under the supervision of a healthcare professional.

Dapoxetine is a prescription drug used to treat premature ejaculation and is not authorized for sale in Canada.

Place of origin

Unknown.

Side effects

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.

In addition, 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.

Side effects associated with dapoxetine may include seizures, changes in blood pressure, blurred vision, dizziness, headache and nausea.

What you should do

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.

Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.

Background

Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of April 30, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Report a health or safety concern

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.

Images

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