Drug recall
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo…
FDA recall event 87711 · Class II · Hyobin LLC
Key facts
| Event ID | 87711 |
|---|---|
| Recall numbers | D-0381-2021, D-0382-2021, D-0383-2021 |
| Recalling firm | Hyobin LLC |
| Product type | Drugs |
| Products | PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ, PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ, Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. |
| Initiation date | Apr 6, 2021 |
| Report date | May 26, 2021 |
| City | Ridgewood |
| State | NJ |
| Country | United States |
| FEI number | 3018523085 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: