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Solo Slim Extra Strength and Revivexxx Extra Strength
- Starting date:
- November 29, 2010
- Posting date:
- November 29, 2010
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Unauthorized products, Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-120001355
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
-
Solo Slim Extra Strength
(All lots with expiration dates including and prior to August 2013) -
Revivexxx Extra Strength
(All lots with expiration dates including and prior to August 2013)
Manufacturer / Place of origin
EZVille, Ltd., Ronkonkoma, New York, U.S.
Product description
Solo Slim Extra Strength is promoted as a dietary supplement used for weight loss. It is packaged in white plastic bottles with blue screw-on cap containing 30 capsules per bottle and bears UPC 8 35470 00220 5.
Revivexxx Extra Strength is promoted as a dietary supplement used for male sexual enhancement. It is packaged in a single dose blister pack containing one oral tablet and bears UPC 8 35470 00207 9.
Reason for warning
The U.S. FDA informed consumers of a recall of these products after FDA tests found Solo Slim Extra Strength to contain undeclared didesmethyl sibutramine, which is an unauthorized substance similar to sibutramine and may pose similar health risks, and Revivexxx Extra Strength to contain undeclared tadalafil.
Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. Tadalafil is a prescription drug used to treat erectile dysfunction and should be taken only under the supervision of a health care practitioner.
According to company-issued news releases, these products were sold to distributors and retail stores nationwide in the U.S. and via internet sales. Consumers were advised to stop using the product and return it to the place of purchase, or to contact EZVille, Ltd. directly at 1-866-673-8483 for more information on the recall.
In 2008, Health Canada issued a Foreign Product Alert for a product named Soloslim, which was also manufactured by EZVille, Ltd. and found to contain an undeclared substance similar to sibutramine.
Possible side effects
In addition to heart attack and stroke, side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.
Tadalafil 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
