FDA recall D-0225-2025

Fagron Compounding Services · Class II · drug

Product

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Reason for recall

Lack of Assurance of Sterility

Distribution

Distributed in PA

Key facts

Status: Completed
Initiation date: 2025-01-31
Report date: 2025-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0225-2025