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Posted May 28, 2003

Warning and Recall for "Herbal" Sexual Enhancement Supplement in Canada Illegally Containing Pharmaceutical Compound

On May 27, 2003 - Health Canada warned consumers not to use Hua Fo VIGOR-MAX tablets, a Chinese herbal product that contains tadalafil. Tadalafil (CialisĀ®)is a prescription drug approved for sale for male erectile dysfunction in the UK, Germany, Sweden, Denmark, Finland, New Zealand, Australia and Singapore. It is not approved for sale in Canada. Inappropriate use of Tadalafil could cause severe adverse reactions.

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. (See archive on ConsumerLab.com). 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 required the importer to remove the product from the shelves. Health Canada is again 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.

Hua Fo is manufactured in China and sold in Canada by Shenlong Natural International Inc. The product (Hua Fo VIGOR-MAX Herbal Sexual Enhancer - Natural) is packaged in white plastic bottles containing red coloured, round, biconvex tablets. A red label indicates "300 mg. 30 tablets, Lot Number 5444 Exp DE2007. Dosage: For adults only, take 5 tablets one hour before intercourse." 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). A picture of the product is available on Health Canada's website at http://www.hc-sc.gc.ca.

Health Canada is issuing this warning to advise consumers, health care professionals, and the provincial Ministries of Health of the safety issues related to the use of Hua Fo VIGOR-MAX. Consumers are reminded to consult with their health care practitioner if they have experienced any adverse effects from taking Hua Fo VIGOR-MAX.