July 29, 2009
Nutracoastal Trading LLC is recalling dietary supplements sold under the STEAM and S-DROL names after FDA analysis found the products contained ingredients that made them unapproved drugs.
S-DROL was found to contain desoxymethyltestosterone, a steroid, it an unapproved drug. The active drug ingredient is not listed on the product label. Samples of STEAM tested by the FDA contained sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED).
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
S-DROL was distributed in black plastic bottles to retail stores nationwide. STEAM was distributed in white plastic bottles.
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.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088].
Consumers should return any unused products to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.