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
Reported: April 10, 2024 Initiated: February 29, 2024 #D-0436-2024
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
Reason for Recall
Lack of Assurance of Sterility: Firm did not perform process validation.
Details
- Recalling Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Units Affected
- 140 vials
- Distribution
- MO
- Location
- Fenton, MO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center. Units affected: 140 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Firm did not perform process validation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2024. Severity: Moderate. Recall number: D-0436-2024.
Related Recalls
NHTSA Critical
LEXUS 2025: POWER TRAIN:AUTOMATIC TRANSMISSION
LEXUS · 2026-02-18
NHTSA Critical
CADILLAC,CHEVROLET,GMC 2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CADILLAC,CHEVROLET,GMC · 2026-02-13
NHTSA Critical
CHEVROLET,GMC 2020-2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CHEVROLET,GMC · 2026-02-12
NHTSA Critical
CADILLAC 2024: BACK OVER PREVENTION:SOFTWARE
CADILLAC · 2026-02-12
NHTSA Critical
NISSAN 2024-2025: FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM:THROTTLEBODY/MANIFOLD
NISSAN · 2026-02-12