LibieXtreme, Y-4ever, Powermania (liquid and capsule), Libimax X, Herbal Disiac

Foreign Product Alert
2009-147
September 3, 2009
For immediate release

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

Source of Alert: U.S. Food and Drug Administration
Product Names: LibieXtreme, Y-4ever, Powermania (liquid and capsule), Libimax X, Herbal Disiac
Manufacturer / Place of Origin: Nature & Health Co., Brea, California, USA

Product Description
These products are promoted as natural dietary supplements used for male sexual enhancement, and come packaged as follows:

LibieXtreme, 1-capsule packet:

Y-4ever, 1-capsule packet:

Powermania (liquid), 1 fl. oz. packet:

Libimax X , 1 fl. oz. packet:

Herbal Disiac, 40-capsule bottle:

Reason for Warning
The U.S. Food and Drug Administration informed consumers of a voluntary recall by the manufacturer after FDA tests found the above-named products to contain undeclared tadalafil, or unauthorized substances similar to tadalafil or sildenafil, as follows:

Product	Pharmaceutical ingredient
LibieXtreme	Aminotadafil
Y-4ever	Sulfoaidenafil
Powermania (capsule)	Sulfoaidenafil
Powermania (liquid)	Sulfoaidenafil
Libimax X	Aminotadafil
Herbal Disiac	Tadalafil

Tadalafil and sildenafil are prescription drugs used to treat erectile dysfunction. They should only be taken under the supervision of a health care practitioner.

Health Canada has already issued a Foreign Product Alert on Libimax, a product similar in name to "Libimax X" and also manufactured by Nature & Health Co.

Possible Side-Effects
Tadalafil and sildenafil 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 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 products 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.