Recalling firm
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Product type
Drug
Status
Ongoing
Report date
2024-04-10
Distribution
MO
Firm state
MO
Product quantity
140 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility: Firm did not perform process validation.
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
Code / lot info
Lot: 20231031-0C91D9, Exo 29-Feb-2024.
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.