December 16, 2009
Atlas Operations' dietary supplements for sexual enhancement recalledThe FDA and Atlas Operations have notified consumers of a voluntary nationwide recall of the company's dietary supplements for sexual enhancement. FDA lab analyses found certain batches of the product to contain undeclared sulfoaildenafil, an unapproved analog of sildenafil, an FDA-approved drug used in the treatment of erectile dysfunction. Sulfoaildenafil may pose a threat to consumers because of its interaction with some prescription drugs (eg, nitroglycerin) that may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs.
The products being recalled are sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807. A full list of product names and lots being recalled can be found at www.fda.gov/Safety/Recalls/ucm194074.htm.
Consumers who have these products in their possession should stop using them immediately and contact their healthcare provider if they experience any adverse events associated with the use of sexual enhancement products.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194091.htm.