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

Starting date:
March 7, 2016
Posting date:
March 7, 2016
Type of communication:
Advisory
Subcategory:
Drugs, Natural health products
Source of recall:
Health Canada
Issue:
Product withdrawal, Important Safety Information
Audience:
General Public
Identification number:
RA-57436

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.

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 Daily, Forta Xpload and Durazest For Men Volume, particularly those with heart conditions.

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.

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.

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

Images

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