The US Food and Drug Administration (FDA) has initiated a nationwide recall of a Nutracoastal Trading LLC dietary supplement product sold under the name Steam.
FDA analysis of the product revealed an undeclared ingredient, sulfoaildenafil – an analogue of sildenafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) – making the product an unapproved drug.
The FDA believes the undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin, often used by patients with diabetes, high blood pressure, high cholesterol or heart disease and may lower blood pressure to dangerous levels. Additionally, the product may cause side effects, such as headaches and flushing.
A statement released by Nutracoastal Trading LLC said that no illnesses had been reported to the company to date but confirmed that customers who have this product in their possession should stop using it immediately, and contact their physician if they have experienced any problems that may be related to taking this product.
The recalled product was distributed in white plastic bottles to retail stores nationwide.