FDA recall D-0368-2021

QMart · Class II · drug

Product

IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2021-03-31
Report date: 2021-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2021