X-Hero - Male Enhancer - Foreign Product Alert 2011-07-12 - Health Canada

Foreign Product Alert
2011-96
July 12, 2011
For immediate release

Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects. More info

Source of Alert

U.S. Food and Drug Administration

Product Names

X-Hero
Male Enhancer

Manufacturer / Place of Origin

USA Far Ocean Group Inc., of Alhambra, California, USA

Product Description

X-Hero and Male Enhancer are promoted for male sexual enhancement, and come packaged as follows:

Product	Package Size	UPC Codes
X-Hero (English Label)	10 capsules	689087070995
X-Hero (English Label)	8 capsules	689076499255
X-Hero (Chinese/English Label)	8 capsules	689076499255
X-Hero (English Label)	1 capsule pack	None
Male Enhancer	60 capsules	982010061205

Reason for Warning

The U.S. FDA informed consumers of a voluntary recall after X-Hero was found to contain undeclared sulfosildenafil while Male Enhancer was found to contain undeclared tadalafil.

Sulfosildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner.

According to the company news release, X-Hero and Male Enhancer were distributed nationwide in the U.S. via retail stores, Internet sales and mail order.

Possible Side-Effects

Sildenafil or tadalafil should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

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Media Enquiries:
Health Canada
613-957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.