Foreign Product Alert: VitaliKOR

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-39635

Introduction

This product is not authorized for sale in Canada and has not been found in the Canadian marketplace, but it is possible it may have been brought into the country by travellers or purchased over the Internet.

Affected product

  • VitaliKOR

VitaliKOR Fast Acting

Product description

This product is promoted for sexual enhancement. The product is found in a clear plastic bottle with 40 light blue capsules. The affected lots are K58Q and F50Q.

Hazard identified

The United States Food and Drug Administration (US FDA) warned consumers not to use this product after it was found to contain vardenafil and tadalafil.

Vardenafil 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

According to the product packaging, the product is distributed by Vitality Research Labs, Las Vegas, Nevada, USA.

Side effects

Vardenafil and tadalafil should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they 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.

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 product listed above in the Canadian marketplace.

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

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 this product 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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