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.
Recall initiated: 20240229
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated