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

4 FDA enforcement actions

4 Total Recalls

0 Class I

4 Class II

0 Class III

Firm Details

Product Types: drug
States: MO

All Recalls

Class II: Risk 02/29/2024 drug

Lack of Assurance of Sterility: Firm did not perform process validation.
Class II: Risk 02/29/2024 drug

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

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 drug

Lack of Assurance of Sterility

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.