SSM Health Care St. Louis DBA SSM St. Clare Health Center: Drug Recall

Recall #D-0436-2024 · 02/29/2024

Class II: Risk

Recall Details

Recall Number: D-0436-2024
Classification: Class II
Product Type: Drug
Recalling Firm: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Status: Ongoing
Date Initiated: 02/29/2024
Location: Fenton, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 140 vials

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

Distribution Pattern

Other Recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Class II: Risk 02/29/2024

Lack of Assurance of Sterility: Firm did not perform process validation.
Class II: Risk 05/09/2023

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II: Risk 09/22/2021

Lack of Assurance of Sterility

View all recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.