FDAFDA · Food and drugs·Recall number D-0436-2024
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
Published April 10, 2024 · Recall initiated: February 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Firm did not perform process validation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Distributor
- MO
- Lot
- Lot: 20231031-0C91D9, Exo 29-Feb-2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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