FDA recall D-0654-2020

Product

Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, 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-0654-2020