RockHard Weekend and Pai You Guo

Starting date:

January 6, 2010

Posting date:

January 6, 2010

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-120001152

• Media enquiries
• Public enquiries

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 (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 and 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.

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.

Media enquiries

Health Canada
613-957-2983

Public enquiries

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