FDA recall D-1292-2019

D.B.P. Distribution · Class I · drug

Product

Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020

Reason for recall

Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2019-04-23
Report date
2019-05-22
Termination date
2023-03-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chatsworth, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1292-2019