FDA MedWatch – PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 by Yolo Studio:

TOPIC: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 by Yolo Studio: Recall – Due to to the Presence of Undeclared Tadalafil

AUDIENCE: Consumer, Health Professional

ISSUE:  Yolo Studio is recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 because FDA analysis has found the product to contain undeclared tadalafil. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, phosphodiesterase (PDE- 5) inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Yolo Studio has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Tadalafil is an ingredient known as a PDE-5 inhibitor found in FDA approved products for the treatment of male erectile dysfunction. These tainted products are marketed as dietary supplements for male sexual enhancement.

RECOMMENDATIONS: 

• On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.
• Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them.
• Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.