FDA recall D-0353-2021

Na Na Collection · Class II · drug

Product

PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006

Reason for recall

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

Distribution

Nationwide with the United States

Key facts

Status
Ongoing
Initiation date
2021-03-30
Report date
2021-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2021