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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 Ongoing Historical recordClass II

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

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

Reason
Lack of Assurance of Sterility: Firm did not perform process validation.
Published
April 10, 2024
Distribution
MO

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FDA Recall Ongoing Historical recordClass II

Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1

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

Reason
Lack of Assurance of Sterility: Firm did not perform process validation.
Published
April 10, 2024
Distribution
MO

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FDA Recall Ongoing Historical recordClass II

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

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

Reason
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.
Published
June 7, 2023
Distribution
Product was distributed in Missouri.

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FDA Recall Terminated Historical recordClass II

Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1

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

Reason
Lack of Assurance of Sterility
Published
October 20, 2021
Distribution
MO

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FDA Recall Terminated Historical recordClass II

Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01

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

Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01

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

Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01

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

Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01

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

Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01

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

Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01

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

HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01

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 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01

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…

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.