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

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
201810
20211
20231
20242
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FDA Recall Terminated Historical recordClass II

Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01

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

Reason
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Published
January 3, 2018
Distribution
SSM Health entities in the state of MO o…

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FDA Recall Terminated Historical recordClass II

Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81

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

Reason
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Published
January 3, 2018
Distribution
SSM Health entities in the state of MO o…

View recall →

This page lists recalls that name SSM Health Care St. Louis DBA SSM St. Clare Health Center as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.