FDA recall D-0366-2021

Antoto-K · Class II · drug

Product

Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2021-03-26
Report date: 2021-05-12
Termination date: 2022-04-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Manassas, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0366-2021