Manufacturer

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

14 recalls in our database name SSM Health Care St. Louis DBA SSM St. Clare Health Center as the manufacturing or recalling firm.

What the numbers show

Total: 14
Critical: 0
Severe: 3
Most recent: 2024-04-10

Of the 14 recalls from SSM Health Care St. Louis DBA SSM St. Clare Health Center we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

HighFDA (Drugs)·D-0436-2024·2024-04-10
Injectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
SSM Health Care is recalling 140 vials of fentanyl citrate injection because the manufacturer did not perform required process validation to ensure sterility.
Product
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
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0435-2024·2024-04-10
Phenylephrine HCl Syringes Recalled for Sterility Assurance Failure
SSM Health Care is recalling 11,798 compounded Phenylephrine HCl intravenous syringes distributed to Missouri hospitals and medical offices due to lack of process validation for sterility assurance.
Product
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
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0776-2023·2023-06-07
FDA Recalls Hydromorphone Injections Due to Discontinued Quality Assurance Program
The FDA is recalling Hydromorphone HCl 10 mg injections due to the manufacturer's discontinuation of its quality assurance program. The product, distributed in Missouri, may not meet standards for strength, purity, and identity.
Product
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
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0007-2022·2021-10-20
Potassium Chloride Injection Recall Due to Sterility Assurance Lack
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
Product
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
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0143-2018·2018-01-03
SSM St. Clare Recalls Oxytocin IV Bags Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Oxytocin IV bags due to a lack of sterility assurance. No distributed product has been identified as actually containing microorganisms.
Product
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
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0144-2018·2018-01-03
SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded phenylephrine syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
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
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0138-2018·2018-01-03
SSM St. Clare Recalls Compounded Fentanyl and Ropivacaine Injectable Bags
SSM St. Clare Health Center is recalling compounded fentanyl and ropivacaine injectable bags due to a lack of sterility assurance. Microbial growth was detected during a routine simulation, though no distributed product was found to contain microorganisms.
Product
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
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0141-2018·2018-01-03
SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
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
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0142-2018·2018-01-03
SSM St. Clare Recalls Norepinephrine IV Bags Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Norepinephrine IV bags in Missouri due to microbial growth detected during a routine manufacturing simulation.
Product
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
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0136-2018·2018-01-03
SSM St. Clare Recalls Fentanyl Vials Due to Sterility Assurance Concerns
SSM St. Clare Health Center is recalling Fentanyl 10 mcg vials because microbial growth was detected during a routine manufacturing simulation. No distributed product has been identified as containing microorganisms.
Product
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
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0145-2018·2018-01-03
SSM St. Clare Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded succinylcholine chloride syringes because microbial growth was detected during a routine manufacturing simulation.
Product
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
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0139-2018·2018-01-03
SSM St. Clare Recalls Hydromorphone PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
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
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0140-2018·2018-01-03
SSM St. Clare Recalls Morphine PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Morphine PCA cartridges due to a lack of sterility assurance detected during routine testing.
Product
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
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0137-2018·2018-01-03
SSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns
SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
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
Category
Drug
Distribution
1 state