Drug 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
D-0436-2024
Product summary
- Event
- Event 94198
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 140 vials
- Official record key
drug-enforcement:D-0436-2024
Official wording
Reason: Lack of Assurance of Sterility: Firm did not perform process validation.
Code information: Lot: 20231031-0C91D9, Exo 29-Feb-2024.
Distribution pattern: MO
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility