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PremierZEN and Triple SupremeZEN Supplements Recalled Due to Undeclared Tadalafil WASHINGTON, DC – According to a recall notice published by the U.S. Food and Drug Administration, Yolo Studio has issued a nationwide recall of its PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 due to the presence of undeclared Tadalafil. The affected Yolo Studio […]
PremierZEN and Triple SupremeZEN Supplements Recalled
WASHINGTON, DC – According to a recall notice published by the U.S. Food and Drug Administration, Yolo Studio has issued a nationwide recall of its PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 due to the presence of undeclared Tadalafil. The affected Yolo Studio products are described as dietary supplements for male sexual enhancement.
The FDA tested the affected products, and the agency’s analysis determined the products contained undeclared Tadalafil. Tadalafil is a phosphodiesterase (PDE5) inhibitor medication that is commonly prescribed to treat male erectile dysfunction. The presence of prescription medications, like Tadalafil, requires FDA approval to check the product’s safety and efficacy prior to the sale in the United States.
Consumers with underlying medical issues such as diabetes, high blood pressure, or heart disease who take one of the recalled products containing undisclosed Tadalafil could suffer a life-threatening lowering of their blood pressure. PDE-5 inhibitors can interact with nitrates used in prescription drugs such as nitroglycerin and other vasodilators.
All lots numbers of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 are being recalled. The male enhancement supplements were sold via the Internet and fulfilled by Amazon.com nationwide. The FDA has warned consumers of purchasing supplements online due to “hidden and potentially dangerous drug ingredients.”
Yolo Studio urges customers to stop using the supplements and throw away all unused PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 supplements.
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