CLASS II Drug recall · Reported 3 Jan 2018 · FDA Enforcement Report
Norepinephrine 8 mg in dextrose 5% IV, Concentration recalled
SSM Health Care St. Louis is recalling Norepinephrine 8 mg in dextrose 5% IV, Concentration: 0.032 mg/mL, This is a compounded, distributed in Missouri. The recall was initiated on 10 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0142-2018
- FDA event ID
- 78678
- Recalling firm
- SSM Health Care St. Louis, Fenton, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2017
- FDA classified
- 28 Dec 2017
- Reported
- 3 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 10 Aug 2017 | Recall initiated by company | |
| 28 Dec 2017 | Classified by FDA | +140 days |
| 3 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
SSM Health entities in the state of MO only
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
SSM Health entities in the state of MO only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 78678More recalls from SSM Health Care St. Louis
All 14Other Norepinephrine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NORepinephrine 4 mg/ added to 0.9% sodium chloride 16 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine, 16 mg, added to dextrose 5%, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8mg in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Norepinephrine in 5% Dextrose Injection, 8 mg recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine, 4 mg per, (18 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |