FDA Drug recall D-0633-2021
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group,…
- FDA Drug
- Class I
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class I recall of PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group,… by Miracle 8989, citing marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0633-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-05-18 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Miracle 8989 |
| Distribution | US |
Product
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Reason
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Identifiers
| upc | 728175421832 |
|---|---|
| code_info | All lots remaining within expiry. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0633-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.