# FDA recall D-0351-2021

> **Namoo Enterprise LLC** · Class II · drug recall initiated 2021-03-25.

## Product

PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006  UPC 7 2817542189 4

## Reason for recall

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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0351-2021
- **Recalling firm:** Namoo Enterprise LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-25
- **Report date:** 2021-05-05
- **Termination date:** 2021-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Little Ferry, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2021

## Citation

> AI Analytics. FDA recall D-0351-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0351-2021. Source: US FDA. Licensed CC0.

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