USA Far Ocean Group Inc is conducting a nationwide recall of the Company's two supplement products sold under the names X-Hero and Male Enhancer. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of X-Hero sample found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug. In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Male Enhancer an unapproved drug.
FDA advised that both products pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that either sulfosidenafil or tadalafil may cause side effects, such as headaches and flushing.
These two products have been distributed nationwide via retail stores, internet sales and mail order. A complete list of the packages of X-Hero and Male Enhancer products involved in this voluntary recall can be found on the FDA website, by clicking on link below.
MAR-28-11: USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall of X-Hero and Male Enhancer, Products Marketed as Dietary Supplements [FDA: RECALLS]