SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx On
Recalled April 10, 2024 · FDA recall D-0436-2024 · SSM Health Care St. Louis
Hazard
Lack of Assurance of Sterility: Firm did not perform process validation. · FDA Class II
Units
140 vials
Sold at
MO
Description
Lack of Assurance of Sterility: Firm did not perform process validation.
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
Manufacturer(s)
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →