**** Recall via Health Canada
Male sexual enhancement product “Harmony” may pose serious health risks
Product: Harmony (NPN 80044321), promoted as a herbal product for male sexual enhancement.
Issue: The product contains high levels of a prescription erectile dysfunction drug, tadalafil, which may pose serious health risks.
What to do: Stop using this product and seek medical advice if you have taken this product and have health concerns.
Issue
Health Canada is warning consumers to not use Harmony, a male sexual enhancement capsule, because it may pose serious health risks. Harmony is promoted as a herbal product for male virility. It was authorized as a natural health product, but Health Canada testing found it contains high levels of a prescription erectile dysfunction drug, tadalafil. The product was not authorized to contain tadalafil, it was not authorized as a sexual enhancement product, and it did not list tadalafil on the product label. As a result, Health Canada has suspended the product licence for Harmony (NPN 80044321). Tadalafil should be used only under the supervision of a health care professional because of the risk of interactions with other medications and side effects. Prescription drugs can only be legally sold via a prescription. In Canada, the maximum dosage authorized in prescription tadalafil for erectile dysfunction is 20 mg per dose. Harmony samples were found to contain approximately three times that amount per capsule. Tadalafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine), regularly or intermittently, since it can cause a potentially life-threatening decrease in 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 heartbeat. Other possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss. Health Canada executed a search warrant and seized the product from three stores, and directed a fourth store to remove it from sale. The stores are:
- Male & Female Harmony Adult Boutique, 1402 W. Broadway, Vancouver, B.C. (product was seized)
- Male & Female Harmony Store, 1030 – 4540 No. 3 Road, Richmond, B.C. (product was seized)
- Love in Love Adult Store, 4554 Kingsway, Burnaby, B.C. (also known as Male & Female Harmony Store) (product was seized)
- Love Net Adult Boutique, 4687 Kingsway, Burnaby, B.C. (retailer removed the product from shelves)
The Department is investigating the issue and will take additional action as needed. If additional safety concerns are identified involving this product, Health Canada will inform Canadians.
What you should do
- Stop using this product.
- Contact your health care practitioner if you have used this product and have concerns about your health.
- Report any health product adverse events or complaints to Health Canada.
