D-0381-2021 Class II Ongoing

Recalled by Hyobin LLC — Ridgewood, NJ

Recall Details

Product Type
Drugs
Report Date
May 26, 2021
Initiation Date
April 6, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 cards

Product Description

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

Reason for Recall

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

Distribution Pattern

USA Nationwide

Code Information

all lots