CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Sterile Water for Injection recalled by Nephron Sc
Nephron Sc is recalling Sterile Water for Injection, USP, For Drug Diluent Use Only Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 12 Jan 2023 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-0178-2023
- FDA event ID
- 91449
- Recalling firm
- Nephron Sc, West Columbia, SC
- Brand
- Sterile Water
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2023
- FDA classified
- 24 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jan 2023 | Recall initiated by company | |
| 24 Jan 2023 | Classified by FDA | +12 days |
| 1 Feb 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: potential for trace amounts of product carryover.
Product as listed by the FDA
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: potential for trace amounts of product carryover.
Which lots are affected?
Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Where was it sold?
Nationwide in the USA
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
1 other product · FDA event 91449This product is part of a recall event; the main page for the event is 0.9% Sodium Chloride Injection, USP Single-Dose Container recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 0.9% Sodium Chloride Injection, USP Single-Dose Container recalledSodium Chloride | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Nephron Sc
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | Nationwide |
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Asthmanefrin Racepinephrine Inhalation Solution recalled by Nephron Sc | Nephron Sc | Packaging Defects | Nationwide |
| Drug | CLASS II | S2 Racepinephrine Inhalation Solution recalled by Nephron ScS2 | Nephron Sc | Packaging Defects | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection, USP Single-Dose Container recalledSodium Chloride | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
Other Water recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Water for Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Irrigation, Single-Dose recalled by Baxter HealthcareSterile Water | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Sterile Water For Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Sterile Water for Injection recalled by Mckesson Medical-SurgicalSterile Water | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |