SSM St. Clare Health Center Recalls Norepinephrine IV Bags Due to Microbial Growth Risk
SSM St. Clare Health Center recalls specific norepinephrine IV bags (NDC 88890-0334-01) due to microbial growth detected in manufacturing simulations. No actual contaminated batches were found, but the risk requires immediate action.
Lower-risk recall
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.
Contact the company
What happened, in plain English
SSM St. Clare Health Center has recalled certain norepinephrine IV bags because testing found microbial growth during manufacturing simulations. This could pose a risk of infection if the product is used improperly, though no actual contaminated batches were identified. Read more at govinfonow.com/recall/41396-ssm-st-clare-health-center-recalls-norepinephrine-iv-bags-due.
Source Summary by GovInfoNow · govinfonow.com/recall/41396-ssm-st-clare-health-center-recalls-norepinephrine-iv-bags-due · Updated October 7, 2026 · FDA enforcement record: FDA #D-0142-2018
Cite this page
“SSM St. Clare Health Center Recalls Norepinephrine IV Bags Due to Microbial Growth Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41396-ssm-st-clare-health-center-recalls-norepinephrine-iv-bags-due. Based on FDA recall #D-0142-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0142-2018%22&limit=1).
Why it’s dangerous
The recall is based on microbial growth detected during routine manufacturing simulations, indicating a lack of sterility assurance. However, no actual batches of the product were found to contain microorganisms, so the risk is theoretical and not immediate.
Who’s affected
Healthcare providers and hospitals that use these specific norepinephrine IV bags for intravenous administration. Patients receiving treatment with these bags are at risk if the product is not properly handled.
How to tell if you have this one
Check for the NDC number 88890-0334-01 on the IV bag label. The product was distributed in specific lots with expiration dates from September 2017 through October 2017.
- Brand
SSM St. Clare Health Center- Category
Drug
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
SSM Health entities in the state of MO only
| Recall number | Product, codes & lots |
|---|---|
| D-0136-2018 | 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; Lot: 170614-006, exp 9/12/2017 |
| D-0137-2018 | 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; Lot: 170711-005, 10/09/2017 |
| D-0138-2018 | 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; Lot, exp: 170621-008, 09/19/2017; 170703-002, 10/01/2017; 170711-031, 10/09/2017 |
| D-0139-2018 | 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; Lot, exp: 170615-004, 9/13/2017; 170720-009, 10/18/2017 |
| D-0140-2018 | 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; Lot, exp: 170627-012, 9/25/2017; 170629-019, 9/27/2017 |
| D-0141-2018 | 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; Lot: 170705-002, 10/03/2017 |
| D-0142-2018 | 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; Lot, exp: 170614-007, 9/12/2017; 170628-001, 9/26/2017; 170703-017, 10/1/2017; 170706-009, 10/4/2017; 170719-007, 10/17/2017 |
| D-0143-2018 | 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; Lot, exp: 170619-011, 9/17/2017; 170707-007, 10/5/2017; 170713-009, 10/11/2017 |
| D-0144-2018 | 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; Lot, exp: 170622-007, 9/20/2017; 170710-007, 10/8/2017 |
| D-0145-2018 | 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; Lot, exp: 170620-005, 9/18/2017; 170626-003, 9/24/2017 |
What to do — step by step
Check Product Label
Look for the NDC number 88890-0334-01 on the IV bag to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed in Missouri.
FDA distribution: “SSM Health entities in the state of MO only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any injuries reported?
No injuries have been reported as of the recall announcement.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0142-2018 (August 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0142-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.