FDA recall D-0436-2024

Product

FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1

Reason for recall

Lack of Assurance of Sterility: Firm did not perform process validation.

Distribution

MO

Key facts

Status

Ongoing

Initiation date

2024-02-29

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fenton, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2024