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
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
SSM Health Care St. Louis DBA SSM St. Clare Health Center — Class II Recall | MedicineWatch US