FDA recall D-0381-2021

Hyobin LLC · Class II · drug

Product

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

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2021-04-06
Report date
2021-05-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ridgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0381-2021