Reesna Inc., Canoga Park, CA, is voluntarily recalling all lots of Fuel Up Plus and Fuel Up High Octane particularly distributed in August 2015 due to containing undeclared hydroxythiohomosildenafil, an analogue of sildenafil. Sildenafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Fuel Up an unapproved drug. The problem was found after FDA sampled the product and the results were positive for undeclared hydroxythiohomosildenafil.
About The FDA
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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