SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls
FDA enforcement reports naming SSM Health Care St. Louis DBA SSM St. Clare Health Center as the recalling firm.
- Recall reports
- 14
- Class I (serious)
- 0
- Most recent report
- Apr 10, 2024
- Apr 10, 2024Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only…Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack of Assurance of Sterility: Firm did not perform process validation.Class II
- Apr 10, 2024FentaNYL citrate, 10 mcg in 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack of Assurance of Sterility: Firm did not perform process validation.Class II
- Jun 7, 2023HYDROmorphone HCl 10 mg in 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterCGMP 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
- Oct 20, 2021Potassium Chloride 40 mEq in 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack of Assurance of SterilityClass II
- Jan 3, 2018Morphine 50 mg in 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack 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.Class II
- Jan 3, 2018Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mLDrug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack 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.Class II
- Jan 3, 2018Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack 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.Class II
- Jan 3, 2018Fentanyl 10 mcg in 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack 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.Class II
- Jan 3, 2018Phenylephrine 1000 mcg in 0Drug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack 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.Class II
- Jan 3, 2018Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mLDrug · SSM Health Care St. Louis DBA SSM St. Clare Health CenterLack 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.Class II
- Oxytocin 30 units in 0
- Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1
- Fentanyl 2 mcg/mL and ropivacaine 0
- HYDROmorphone 10 mg in 0
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