Drug product
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
D-0353-2021
Product summary
- Firm
- Na Na Collection
- Event
- Event 87653
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0353-2021
Official wording
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Code information: Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.