Canada recalls Chinese herbal
tablets, a Chinese herbal product found to contain the presription
drug tadalafil, not approved for sale in Canada.
Health Canada is warning consumers not to use Hua Fo VIGOR-MAX tablets, a Chinese herbal product found to contain the presription drug tadalafil, not approved for sale in Canada.
Tadalafil is a drug for male erectile dysfunction, available in the UK, Germany, Sweden, Denmark, Finland, New Zealand, Australia and Singapore. The agency is requiring the importer to remove Hua Fo VIGOR-MAX from the market and has issued a Customs Alert to stop the importation of the product.
The health agency has warned that Tadalafil should not be used by individuals who are taking any medication or other products containing nitrates: concurrent use could result in the development of potentially life-threatening low blood pressure. Also, tadalafil should not be used by patients with severe renal or hepatic insufficiency.
Health Canada issued previous warnings on February 15, 2002 and April 5, 2002 concerning different lots of the product Hua Fo. These products were found to contain sildenafil, or a compound similar, but not identical to sildenafil, respectively. Like, tadalafil, sildenafil and its analogue are used to treat erectile dysfunction. At the time, Health Canada also required the importer to remove the product from the shelves.
Hua Fo is manufactured in China and sold in Canada by Shenlong Natural International. Health Canada analyzed several tablets and found them to contain tadalafil at an average concentration of about 3 mg per tablet (normal concentration of Tadalafil is 10 mg or 20 mg).