Drug recall
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed…
FDA recall event 91711 · Class I · Volt Candy Wholesale Club
Key facts
| Event ID | 91711 |
|---|---|
| Recall numbers | D-0453-2023 |
| Recalling firm | Volt Candy Wholesale Club |
| Product type | Drugs |
| Products | PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male… |
| Initiation date | Feb 13, 2023 |
| Report date | Mar 8, 2023 |
| Termination date | Aug 20, 2024 |
| City | Diamond Bar |
| State | CA |
| Country | United States |
| FEI number | 3025403089 |
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: