TWC Global LLC, Inc., in conjunction with the FDA, is recalling Axcil and Desirin products marked as dietary supplements because they include potentially dangerous unlabeled ingredients.
FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals 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.
Consumers who have diabetes, high blood pressure, heart disease of have high cholesterol may take nitrates for their condition. These consumers often have problems with sexual dysfunction and may take these type of products to improve sexual performance.
Axcil and Desirin are sold throughout the U.S. on the Internet. The pills are sold as a 15-capsule blister pack packaged in a box.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.