FDA recall D-0351-2021

Namoo Enterprise LLC · Class II · drug

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 for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2021-03-25
Report date
2021-05-05
Termination date
2021-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Ferry, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2021