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Archived – Fortodol
- Starting date:
- June 3, 2009
- Posting date:
- June 3, 2009
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-120001096
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.K. Food Standards Agency
- U.K. Medicines and Healthcare products Regulatory Agency
- Swedish Medical Products Agency
- Norwegian Medical Products Agency
- Food Safety Authority of Ireland
Product name
Fortodol, which is also sold under the names:
- Donsbach Miradin
- Lepicol Miradin
- Leppin Miradin
- Miradin
Manufacturer / Place of origin
Manufactured by Donsbach, California, U.S.A.:
- Distributed in Sweden by Hela Pharma
- Distributed in the U.K. by Lepicol Ltd
- Distributed in Northern Ireland by Natural Health Products
Product description
Fortodol, which is also sold under the product names listed above, is promoted as an herbal, turmeric-based dietary supplement used to relieve pain and inflammation.
Reason for warning
Several foreign regulatory agencies (listed above) have warned consumers not to buy or use Fortodol (also sold under other product names, listed above) after it was found to contain the pharmaceutical ingredient nimesulide.
Nimesulide is a drug in the family known as non-steroidal anti-inflammatory drugs (NSAID) and is used to treat pain, fever and inflammation. It is not authorized in Canada because of its association with liver damage.
Possible side effects
In addition to the risk of liver damage, side-effects associated with nimesulide include gastrointestinal bleeding, anemia, kidney failure and reduced blood clotting ability.
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