FDA recall D-0318-2017

Tri-Coast Pharmacy · Class II · drug

Product

TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2016-11-17
Report date
2017-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Juno Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0318-2017