Class II
Ongoing
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
This recall is currently active, issued April 10, 2024. It was issued by Ssm Health Care St. Louis Dba Ssm St. Clare Health Center.
- Recall Initiated
- February 29, 2024
- Posted
- April 10, 2024
- Recall Number
- D-0436-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 140 vials
- Firm Location
- Fenton, MO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Firm did not perform process validation.
Distribution
MO
Lot / Code Info
Lot: 20231031-0C91D9, Exo 29-Feb-2024.
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