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SSM Health Care St. Louis DBA SSM St. Clare Health Center FDA Recalls
4 recalls on file across drugs, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This Class IIFeb 29, 2024Lack of Assurance of Sterility: Firm did not perform process |
| FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx OnClass IIFeb 29, 2024Lack of Assurance of Sterility: Firm did not perform process |
| HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation OutsouClass IIMay 9, 2023CGMP Deviations: Discontinuation of the Quality program by m |
| Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 BowlClass IISep 22, 2021Lack of Assurance of Sterility |