FDA recall D-0657-2020

Motto International Corp · Class I · drug

Product

Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Distribution

TX

Key facts

Status
Terminated
Initiation date
2019-12-17
Report date
2020-01-22
Termination date
2021-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0657-2020