Drug product
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
D-0351-2021
Product summary
- Event
- Event 87609
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0351-2021
Official wording
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Code information: All lots within expiry
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.