Recalls / Class II
Class IID-0436-2024
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
- Affected lot / code info
- Lot: 20231031-0C91D9, Exo 29-Feb-2024.
Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
Recalling firm
- Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1015 Bowles Ave, Fenton, Missouri 63026-2394
Distribution
- Quantity
- 140 vials
- Distribution pattern
- MO
Timeline
- Recall initiated
- 2024-02-29
- FDA classified
- 2024-04-04
- Posted by FDA
- 2024-04-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0436-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.