Drug product
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
D-0382-2021
Product summary
- Firm
- Hyobin LLC
- Event
- Event 87711
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 500 cards
- Official record key
drug-enforcement:D-0382-2021
Official wording
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Code information: all lots
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.