Sex enhancement product recalled after Health Canada test finds undeclared drug ingredient

Health CanadaDec 31 2014

The issue:

One lot of the sex enhancement product "Forta for Men" (NPN 80045132) is being recalled after Health Canada testing confirmed it contains an undeclared drug: homosildenafil. Homosildenafil is similar to the prescription drug sildenafil and may pose serious health risks.

The distributor, Vivo Brand Management Inc. of Cornwall, ON, is recalling the affected lot (LOT:318, EXP: 2017.03), which was sold through retail stores across the country and online.

Products affected:
Forta for Men (NPN 80045132), available in packs of 2 and 10 capsules, LOT: 318, EXP: 2017.03

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. Should additional lots be identified, Health Canada will take appropriate action and inform Canadians.

Background:

Homosildenafil is an unauthorized substance similar to sildenafil. Sildenafil should only be used under the supervision of a healthcare practitioner. Products containing sildenafil or similar substances (known as analogs) 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 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.