CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
0.9% Sodium Chloride Injection, USP Single-Dose Container recalled
Nephron Sc is recalling 0.9% Sodium Chloride Injection, USP Single-Dose Container, 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-0177-2023
- FDA event ID
- 91449
- Recalling firm
- Nephron Sc, West Columbia, SC
- Brand
- Sodium Chloride
- 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
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 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?
Lot: 271043, Exp. 03/2023
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 91449| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterile Water for Injection recalled by Nephron ScSterile Water | 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 | Sterile Water for Injection recalled by Nephron ScSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
Other Sodium Chloride recalls
All 133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |