USA Far Ocean Group Inc., of Alhambra, California, is conducting a product recall of two of its counterfeit supplement products: <"http://www.yourlawyer.com/practice_areas/defective_drugs">X-Hero and Male Enhancer, the U.S. Food and Drug Administration (FDA) just announced.
FDA representatives conducted a lab analysis of a sample of X-Hero and found that it contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED). This makes X-Hero an unapproved drug.
The FDA also analyzed a sample of Male Enhancer and found it, too, contains tadalafil, the active ingredient of an FDA-approved drug used to treat ED, making Male Enhancer an unapproved drug.
The agency advises 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.
The FDA also states that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that either sulfosildenafil 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. All of the following packages of X-Hero and Male Enhancer products are involved in this voluntary recall:
â€¢ X-Hero with English Label: 10 capsules, UPC 689087070995
â€¢ X-Hero with English Label: 8 capsules, UPC 689076499255
â€¢ X-Hero with Chinese/English Label: 8 capsules, UPC 689076499255
â€¢ X-Hero with English Label: 1 capsule pack, no UPC
â€¢ Male Enhancer: 60 capsule, UPC 982010061205
The FDA is advising consumers who have X-Hero or Male Enhancer in their possession to stop using it immediately and to contact their physician if they experienced any problem that may be related to taking this product. To date, no illnesses have been reported to the firm in connection with these products.
Consumers in possession of the recalled products should return any unused products to their immediate supplier for a direct refund. Customers with questions can call the firm at 1.909.839.3058 Monday through Sunday between 9:00 a.m. and 5:00 p.m. for further instructions or information on about the return and refund process.
Any adverse reactions or quality problems experienced with the use of any counterfeit products may be reported to the FDAâ€™s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
â€¢ Online: http://www.fda.gov/MedWatch/report.htm
â€¢ Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.
â€¢ Fax: 1-800-FDA-0178â€¨â€¨