CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Sterile Water for Injection, USP, mL Single-Dose Vials recalled
Nephron Sc is recalling Sterile Water for Injection, USP, mL Single-Dose Vials. The recall was initiated on 23 Feb 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-0364-2023
- FDA event ID
- 91767
- Recalling firm
- Nephron Sc, West Columbia, SC
- Brand
- Sterile Water
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2023
- FDA classified
- 1 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Feb 2023 | Recall initiated by company | |
| 1 Mar 2023 | Classified by FDA | +6 days |
| 8 Mar 2023 | Published in enforcement report | +7 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 product carryover.
Product as listed by the FDA
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
Where it was distributed
United States
Questions about this recall
Why was it recalled?
CGMP Deviations: Potential product carryover.
Which lots are affected?
Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
Where was it sold?
United States
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.
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 | 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 | Sterile Water for Injection recalled by Nephron ScSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | 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 recalled by Nephron ScSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sterile Water for Injection recalled by Mckesson Medical-SurgicalSterile Water | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |