FDA recall D-0453-2023

Product

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-02-13

Report date

2023-03-08

Termination date

2024-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Diamond Bar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2023