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RockHard Weekend and Pandora
- Starting date:
- February 3, 2011
- Posting date:
- February 3, 2011
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Unauthorized products, Product Safety
- Audience:
- General Public
- Identification number:
- RA-120001628
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
Product names
- RockHard Weekend (lots 100159 and 100260 sold as blister packs, 3-count bottles and 8-count bottles)
- Pandora (lot 100378 sold as blister packs)
Manufacturer / Place of origin
RockHard Laboratories
Product description
RockHard Weekend and Pandora are promoted as dietary supplements used for sexual enhancement.
Reason for warning
The U.S. FDA informed consumers of a nationwide voluntary recall of certain lots (see above) of RockHard Weekend and Pandora after lab tests confirmed the products contain an unauthorized substance similar to sildenafil that may pose similar heath risks.
Sildenafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner.
Consumers seeking more information on the recall may contact the company directly at 1-877-576-9363.
Health Canada has issued a previous Foreign Product Alert for RockHard Weekend.
Possible side effects
Sildenafil should not 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.
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
