Health Canada

Health Canada

December 13, 2010 11:44 ET

Unauthorized NorthRegentRx Product: ResurreXX Being Recalled From the Canadian Market

OTTAWA, ONTARIO--(Marketwire - Dec. 13, 2010) -

The issue:

Health Canada is informing Canadians that NorthRegentRx has begun to voluntarily recall its product, ResurreXX from the Canadian market. NorthRegentRx is requesting that wholesalers, distributors and retailers stop sale of this product.

ResurreXX, promoted as a dietary supplement, was tested by Health Canada and found to contain an undeclared substance "hydroxyhomosildenafil", which is similar to the prescription medication sildenafil, and may pose potentially serious health risks to consumers. Prescription medications should only be taken under the supervision of healthcare practitioners.

Who is affected:

Canadians who have purchased or used "ResureXX", particularly people with heart problems, those at risk of stroke, or those taking any nitrate drug (e.g. nitroglycerine).

What consumers should do:

  • Consult your healthcare practitioner if you have used this product and are concerned about your health.

  • 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), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products (NHPs) may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.

  • Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing:

Health Canada will monitor the voluntary recall by NorthRegentRx.

Background:

Sildenafil is a prescription medication used to treat erectile dysfunction and should only be taken under the supervision of a healthcare practitioner. As outlined in the Canadian prescribing information for products containing sildenafil, sildenafil should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as this combination could 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 heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Photos are available at the following address: http://media3.marketwire.com/docs/Products_Health_Can_1213.pdf

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and send to us using one of these methods:

Fax: 1-866-678-6789
   
E-mail: CanadaVigilance@hc-sc.gc.ca
   
Internet: www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php
   
Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701C
  K1A 0K9

Related Health Canada Web content:

- Advisory (July 22, 2010) - Unauthorized Health Product: "SX Male Enhancement" May Pose Serious Health Risks (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_125-eng.php)

- Advisory (July 13, 2010) - Unapproved Health Product "UP Ultimate Performance For Men" May Pose Serious Health Risks (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_117-eng.php)

- Advisory (March 8, 2010) - Unapproved Health Product, "POWER-MAX" May Pose Serious Health Risks (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_34-eng.php)

- Advisory (January 8, 2010) - Canadians Advised Not to use "Stiff Nights" or Any Unauthorized Product Promoted for Erectile Dysfunction (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_05-eng.php)

- Warning (November 25, 2009) - Health Canada Warns Consumers Not to Use "Once More" or Any Unauthorized Product Promoted to Enhance Male Sexual Performance (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_189-eng.php)

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories (http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/).

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

Egalement disponible en francais

Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709