FDA Drug recall D-0351-2021
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542…
- FDA Drug
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542… by Namoo Enterprise, citing marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0351-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-25 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Namoo Enterprise |
| Distribution | US |
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
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Identifiers
| upc | 728175421894 |
|---|---|
| code_info | All lots 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-0351-2021%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.