Two food supplements are the subject of a voluntary recall by the Food and Drug Administration because they contained unapproved drugs.
Nutracoastal Trading LLC is recalling both their STEAM and S-DROL dietary supplements.
STEAM was found to contain sulfoaildenafil, an analog of sildenafil, which is an active ingredient of an FDA-approved drug for erectile dysfunction and S-DROL contains desoxymethyltestosterone, a steroid. Neither drug is listed on the product labels, and those elements in each product make them unapproved drugs.
The undeclared ingredient 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.
No illnesses have been reported to the company to date in connection with these products.
S-DROL was marketed in bottles of 60 tablets and the affected batch carries an expiration date of 01 2012, lot #810481, with a UPC of 8 272386 000376. STEAM was marketed in bottles of five capsules with a lot # 80214 and a UPC of 8 52263 30033 1.
Consumers with the products should stop using them immediately and contact their physicians if they have experienced any problems. Adverse effects should be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm . Product can be returned to the retail location where it was purchased.