← FDA ENFORCEMENT
D-0436-2024Class II

SSM Health Care St. Louis DBA SSM St. Clare Health Center

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 Monitoring
Reason 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.

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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.