SSM Health Care St. Louis DBA SSM St. Clare Health Center
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
Lack of Assurance of Sterility: Firm did not perform process validation.
Classification
Class II
Status
Ongoing
Lot
Lot: 20231031-0C91D9, Exo 29-Feb-2024.
Date
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