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Foreign product alert

Z-Rock All Natural Male Supplement, Extra Power powder sachets, Rock Hard for Men tablets, Ultra Men for Men tablets, MMC Maxman IV Erection Enhancer Capsules, Spider Sex, Toha, Dong Qing San Bian Li

Starting date:: December 21, 2012
Posting date:: December 21, 2012
Type of communication:: Foreign Product Alert (FPA)
Subcategory:: Natural health products
Source of recall:: Health Canada
Issue:: Product Safety, Undeclared Substance
Audience:: General Public
Identification number:: RA-16373

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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.

Source of alert

U.S. Food and Drug Administration, Australia Therapeutic Goods Administration, Japan Ministry of Health, Labour and Welfare, and the Hong Kong Department of Health

Product names

Z-Rock All Natural Male Supplement
Extra Power powder sachets
Rock Hard for Men tablets
Ultra Men for Men tablets
MMC Maxman IV Erection Enhancer capsules
Spider Sex
Toha
Dong Qing San Bian Li

Manufacturer / Place of origin

Z-Rock is manufactured by XRock Industries of Fort Lauderdale, Florida.

The manufacturers of the other products are unknown.

Product description

These products (identified here by jurisdiction) are promoted for sexual enhancement.

Reason for warning

Health authorities in the United States, Australia, Japan, and Hong Kong have warned consumers not to purchase or use these products after they were found to contain undeclared drugs or substances, as follows:

Products containing undeclared drugs
Product	Undeclared drug(s)
Z-Rock All Natural Male Supplement	sildenafil and hydroxythiohomosildenafil
Extra Power powder sachets	aminotadalafil
Rock Hard for Men tablets	tadalafil and glibenclamide
Ultra Men for Men tablets	tadalafil and glibenclamide
MMC Maxman IV Erection Enhancer capsules	sildenafil
Spider Sex	pseudovardenafil
Toha	hydroxyhomosildenafil and aminotadalafil
Dong Qing San Bian Li	sildenafil

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

Hydroxythiohomosildenafil and hydroxyhomosildenafil are unauthorized substances similar to sildenafil, and aminotadalafil is an unauthorized substance similar to tadalafil.

Pseudovardenafil is an unauthorized substance similar to vardenafil, a prescription drug used to treat erectile dysfunction.

Glibenclamide (also known as glyburide) is a prescription drug used to treat diabetes. It should only be taken under the supervision of a health care practitioner.

Possible side effects

Sildenafil, tadalafil or vardenafil (or similar substances) should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as the combination 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 heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Side effects associated with glibenclamide include severe low blood sugar which may cause sweating, paleness, chills, headache, dizziness and confusion.

What you should do

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.

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.

Background

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.

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.

Report a health or safety concern

Call toll-free at 1-866-234-2345.
Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.