PremierZEN Platinum 8000 capsule — Class I drug recall D-0634-2021
Terminated recall by Miracle 8989, reported 2021-06-30, distributed nationwide. Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
| Recall number | D-0634-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Miracle 8989, Dallas, TX, United States |
| Recall initiated | 2021-05-18 |
| Classified | 2021-06-22 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-07-12 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00728175421832, 00728175421856 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0634-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.