Gra-MaxX Gold: Seized from "ShopForYou", Vancouver, B.C. due to serious safety risks

Starting date:

November 7, 2014

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Identification number:

RA-42153

• Issue
• Products affected
• What you should do
• Who is affected
• Background
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

An unauthorized health product, Gra-MaxX Gold, was seized by Health Canada as it contains an undeclared drug: N-Ethyl Tadalafil. The product is used to treat erectile dysfunction. The product was tested by Health Canada and removed from sale from ShopForYou, Robson Street, Vancouver, B.C. This product may pose serious risks to the health of Canadians, especially individuals with heart problems.

Products affected

Gra-MaxX Gold.

What you should do

• Consult with your doctor if you have used this product.
• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.
• Report any adverse events to Health Canada.

Who is affected

Consumers who have used or purchased Gra-MaxX Gold.

Background

Tadalafil should only be used under the supervision of a health care practitioner. Products containing tadalafil or its 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, especially if they use tadalafil to help them achieve an erection. Other possible side-effects of using tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Caffeine was also found in the product and was not listed on the product label. Caffeine may pose health risks to people sensitive to its effects.

Media enquiries

Health Canada
(613) 957-29839

Public enquiries

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

What Health Canada is doing

Health Canada has seized the product from ShopForYou.

Images

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