Product: PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
Reason for recall: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Recall initiated: 20210331
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated