PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

Recall Number: D-0381-2021

Firm: Hyobin LLC

Classification: Class II

Status: Ongoing

Report Date: 20210526

Initiation Date: 20210406

Termination Date:

Reason for Recall

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

Product Description

PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ