FDA recall D-0432-2024

Product

fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

Reason for recall

Lack of Assurance of Sterility: leaking bags

Distribution

Nationwide within the U.S

Key facts

Status

Ongoing

Initiation date

2024-03-22

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0432-2024