FDA recall D-0660-2022

Family Pharmacy of Statesville · Class II · drug

Product

Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Reason for recall

Lack of Assurance of Sterility

Distribution

NC only

Key facts

Status
Terminated
Initiation date
2020-08-06
Report date
2022-03-23
Termination date
2023-08-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Statesville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0660-2022