# FDA recall D-0634-2021

> **Miracle 8989** · Class I · drug recall initiated 2021-05-18.

## Product

PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA  90006

## Reason for recall

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0634-2021
- **Recalling firm:** Miracle 8989
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-18
- **Report date:** 2021-06-30
- **Termination date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dallas, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0634-2021

## Citation

> AI Analytics. FDA recall D-0634-2021. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-0634-2021. Source: US FDA. Licensed CC0.

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