Drug product
PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
D-0369-2021
Product summary
- Firm
- QMart
- Event
- Event 87751
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 500 boxes
- Official record key
drug-enforcement:D-0369-2021
Official wording
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Code information: All
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.