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Tager Online, Inc. (operating as Volt Candy) sold "PrimeZEN Black 6000," an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act. FDA laboratory analysis confirmed the product contained undeclared pharmaceutical ingredients—tadalafil and sildenafil (active ingredients in prescription drugs Cialis and Viagra)—which posed serious safety risks including dangerous drops in blood pressure when combined with nitrates commonly taken by patients with heart disease, diabetes, and high cholesterol. The product was also misbranded, with the company marketing and taking orders through its websites voltcandy.com, voltcandyonline.com, premierzen.com, and associated social media pages between December 2022 and March 2023.