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

Starting date:

February 4, 2016

Posting date:

February 4, 2016

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-57002

• Issue
• Products affected
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

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.

Vivo Brand Management is also recalling, as a precautionary measure, all lots of Durazest for Men (NPN 80033381). Durazest For Men is promoted for sexual enhancement and may be marketed as Drs Choice Male, Physicians Choice, Physicians Choice Male, Potent X, X-Delite.  This product was 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".

What you should do

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

Who is affected

Consumers who have bought or used Forta for Men, particularly those with heart conditions.

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.

Report health or safety concerns

• 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.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

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.

Images

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