FDA Recall D-0436-2024

SSM Health Care St. Louis DBA SSM St. Clare Health Center · Fenton, MO

Class II Ongoing 805 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot: 20231031-0C91D9, Exo 29-Feb-2024.

Quantity: 140 vials

Reason for recall

Lack of Assurance of Sterility: Firm did not perform process validation.

Recall record

Recall number: D-0436-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: MO
Recall initiated: 2024-02-29
Classified by FDA Center: 2024-04-04
FDA published: 2024-04-10
Recalling firm: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Firm location: Fenton, MO

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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