Status
Ongoing
Drug Enforcement D-0436-2024
Lack of Assurance of Sterility: Firm did not perform process validation.
Classification
Class II
Report Date
April 10, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 140 vials
- Reason for recall
- Lack of Assurance of Sterility: Firm did not perform process validation.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- MO
Location & Firm
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Address
-
1015 Bowles Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0436-2024
- Event ID
- 94198
- Recall initiation date
- February 29, 2024
- Center classification date
- April 4, 2024
- Code info
- Lot: 20231031-0C91D9, Exo 29-Feb-2024.
- More code info
- —