RockHard Weekend and Pai You Guo

Foreign Product Alert
2010-03
January 6, 2010
For immediate release

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

Source of Alert

U.S. Food and Drug Administration (FDA)

Product Names

1. RockHard Weekend - certain lots only:
   • Blister Pack:
     • Lot T12 705 08 (expires: 10/11)
     • Lot T12 705 09 (expires: 3/12, 8/12)
   • 3-count Bottle:
     • Lot R417 0509 (expires: 09/12)
   • 8-count Bottle:
     • Lot T237-0509 (expires: 06/12)
2. Pai You Guo - all lots

Manufacturer / Place of Origin

RockHard Weekend is manufactured by RockHard Laboratories while Pai You Guo is manufactured by GMP Herbal Products, Inc.

Product Description

RockHard Weekend is promoted as a dietary supplement used for sexual enhancement. It comes packaged in single blister packs, 3-count bottles and 8-count bottles.

Pai You Guo is promoted as a dietary supplement used for weight loss. It comes packaged either in a box of 30 capsules or a 10 g bag of powder.

Reason for Warning

The FDA informed consumers of a voluntary recall of certain lots (listed above) of RockHard Weekend after they were found to contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil.

The FDA also informed consumers of a voluntary recall of Pai You Guo after it was found to contain undeclared sibutramine and phenolphthalein.

Sildenafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a health care practitioner.

Sibutramine is a prescription drug used to treat obesity. It should only be taken under the supervision of a health care practitioner.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer.

Possible Side-Effects

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.

Side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

In addition to an increased risk of cancer, side-effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

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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.