CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
9% Sodium Chloride Injection, USP Single-Dose Container recalled
Nephron Sc is recalling 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
Is 9% Sodium Chloride Injection, USP Single-Dose Container recalled?
Yes. Nephron Sc recalled 9% Sodium Chloride Injection, USP Single-Dose Container on 12 Jan 2023. The recall is Class II and its status is Terminated. Recall number D-0177-2023.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sodium Chloride recalls
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride | Huons Co | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP 900 mg recalled by Fresenius Kabi USASodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP, 900 mg recalled by Fresenius Kabi USASodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP x60, Becton, Dickson recalledSodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP 9% (450 mg per (9 mg per mL) recalledSodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |