US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 25, 2021 (5 years ago)

PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Namoo Enterprise LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0351-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.