Advisory - "Forta for Men" sex enhancement product recalled; contains undeclared drug

OTTAWA, Feb. 4, 2016 /CNW/ -

The issue:

All lots of an authorized natural health product promoted for sexual enhancement, "Forta for Men", are being recalled after Health Canada testing confirmed one lot contains an undeclared drug: tadalafil. Tadalafil is a prescription drug that should only be used under the supervision of a health-care practitioner and may pose serious health risks.

Forta for Men is manufactured by  Natural Performance Products Limited and the distributor, Vivo Brand Management Inc. of Cornwall, ON, is recalling all lots as a precautionary measure. The product is sold through retail stores across the country and online.

Products affected:
Forta for Men (NPN 80045132), available in packs of 2, 10 or 15 capsules.
Alternate names for the Forta for Men product include "Doctor's First for Men" and "Dr. First for Men".

Who is affected:

Consumers who have bought or used Forta for Men, 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 the recall and following up with the distributor to determine the source of the undeclared drug.  

Background:

Tadalafil should only be used under the supervision of a health-care practitioner. Products containing tadalafil 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 tadalafil and engage in sexual activity. Other possible side-effects of using tadalafil 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.

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SOURCE Health Canada

PDF available at: http://stream1.newswire.ca/media/2016/02/04/20160204_C6813_PDF_EN_614228.pdf

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