# FDA recall D-0369-2021

> **QMart** · Class II · drug recall initiated 2021-03-31.

## Product

PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887

## Reason for recall

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0369-2021
- **Recalling firm:** QMart
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-03-31
- **Report date:** 2021-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elmwood Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0369-2021

## Citation

> AI Analytics. FDA recall D-0369-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0369-2021. Source: US FDA. Licensed CC0.

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