Advisory - Vivo Brand Management recalling more natural health products that may contain undeclared drugs that may pose serious health risks

OTTAWA, March 7, 2016 /CNW/ -

The issue:

Vivo Brand Management Inc. is recalling more natural health products promoted for sexual enhancement: Forta for Men Daily, Forta Xpload and Durazest For Men Volume. As in previous recalls, these products may contain an undeclared drug: sildenafil. Sildenafil is a prescription drug that should only be used under the supervision of a health-care practitioner and may pose serious health risks.

Health Canada is in the process of suspending all affected product licences given the inclusion of prescription drug ingredients.

Products affected:

Forta for Men Daily (NPN 80054633), available in bottles of 30 capsules.
Forta Xpload; Durazest For Men Volume; X-Delite Volumizer (NPN 80035218), available in bottles of 60 capsules and blister packs of 2 capsules.

Who is affected:

Consumers who have bought or used Forta for Men Daily, Forta Xpload and Durazest For Men Volume, particularly those with heart conditions.

What consumers should do

• Consult with your doctor if you have used this product and have health concerns.
• Report any adverse events to Health Canada.

What Health Canada is doing:

Health Canada is monitoring this recall and following up with the licence holder to determine the source of the undeclared drug.

Background:

Products containing sildenafil can only be sold pursuant to a prescription. Products containing sildenafil or its analogs (very similar substances) should never 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 including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side-effects if they use sildenafil and engage in sexual activity. Other possible side-effects of using sildenafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

How to report side effects to health products to Health Canada:

• Call 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.

Également disponible en français

SOURCE Health Canada

PDF available at: http://stream1.newswire.ca/media/2016/03/07/20160307_C5985_PDF_EN_637118.pdf

Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709