Health Canada

Health Canada

December 10, 2010 15:33 ET

"Durazest" and "Once More": Certain Lots of Two Male Sex Enhancement Products Recalled as They May Pose Serious Health Risks

OTTAWA, ONTARIO--(Marketwire - Dec. 10, 2010) -

The issue:

Certain lots (listed below) of two health products promoted for male sexual enhancement, "Durazest for Men" and "Once More," have been voluntarily recalled by Natural Performance Products Ltd. Health Canada laboratory tests identified the presence of a chemical similar to tadalafil (nortadalafil) in one lot of each product. Tadalafil is a prescription medication that should only be used under the supervision of a healthcare practitioner. Nortadalafil is not declared on the labels of these products and may pose serious, potentially life-threatening health risks.

Who is affected:

Canadians who have purchased or used any of the recalled lots specified below of "Durazest for Men" or "Once More." Nortadalafil, found in lot 216 of "Durazest for Men" and lot 216 of "Once More," poses particular risk to people with heart problems or at risk of stroke, or taking any nitrate drug (e.g. nitroglycerine).

What consumers should do

• Consult your healthcare practitioner if you have used either product and are concerned about your health.
• Report any adverse reaction potentially related to either product to Health Canada (see below).
• Return any unused product to the place of purchase, or to a pharmacy for safe disposal.

What Health Canada is doing:

Health Canada has monitored the recall, and is issuing this Public Advisory as consumers may still have the products affected by the recall in their homes.

Should Health Canada become aware that affected lots of "Durazest for Men" or "Once More" continue to be sold, or that other lots of the products contain undeclared pharmaceutical ingredients, Health Canada will take appropriate action.

Consumers are encouraged to submit a complaint regarding the sale of this or any other unapproved health product, or regarding the safety, efficacy or quality of a health product, by calling Health Canada's Inspectorate, toll-free, at 1-800-267-9675. For more information, see the guidance document "How to submit a consumer complaint (GUI-044)" available on the Health Canada website. 

To date, no adverse reactions have been reported to Health Canada involving either "Durazest for Men" or "Once More."

Background:

Health Canada tested "Durazest for Men" and "Once More" and found one lot of each product to contain nortadalafil (lot 216 of "Durazest for Men" and lot 216 of "Once More"). Natural Performance Product Ltd. confirmed that same bulk powder had been used to produce these lots. While only one lot of "Durazest for Men" and "Once More" was found to contain nortadalafil, the company voluntarily recalled all existing lots of both products, as follows:

Product Name Lot # Expiry Date
Once More 216* 03.2013
Durazest for Men 216* 03.2013
211 11.2011
201 02.2012
205 05.2012
212 01.2013
717 02.2011

* Indicates that Health Canada tests identified nortadalafil in samples from this lot

According to information from Natural Performance Products Ltd., these products are sold at retail stores nationwide and on the Internet.

Nortadalafil a chemical similar to tadalafil and may pose similar health risks. It is not authorized for sale in Canada.

Tadalafil is a prescription medication used to treat erectile dysfunction and should only be taken under the supervision of a healthcare practitioner. As indicated in the prescribing information for tadalafil drugs, it should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as this combination can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, sudden cardiac death, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss. In extremely rare instances, use of tadalafil may potentially result in penile tissue damage and loss of potency.

Products that have been assessed by Health Canada for safety, effectiveness and quality 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 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. "Durazest" and "Once More" have been assigned EN numbers.

Pictures of the affected products are available at: http://media3.marketwire.com/docs/hea1.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 or complaints to health products:

To report a suspected adverse reaction to these or other health products, please contact Heath Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

  • Fax: 1-866-678-6789
  • Internet: www.healthcanada.gc.ca/medeffect
  • Mail: Canada Vigilance Program
     Marketed Health Products Directorate
     Ottawa, ON, Address Locator 0701E
     K1A 0K9

Related Health Canada Web content:

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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

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Contact Information

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