CLASS II Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
Sodium Chloride Injection 9%, USP, Single-Dose IV recalled
Nephron Sterile Compounding Center is recalling Sodium Chloride Injection 9%, USP, Single-Dose IV, distributed nationwide in the US. The recall was initiated on 10 Feb 2025 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-0257-2025
- FDA event ID
- 96419
- Recalling firm
- Nephron Sterile Compounding Center, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2025
- FDA classified
- 7 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Feb 2025 | Recall initiated by company | |
| 7 Mar 2025 | Classified by FDA | +25 days |
| 19 Mar 2025 | Published in enforcement report | +12 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 Assurance of Sterility: There is a potential for leakage at the IV bottle port.
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
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Which lots are affected?
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Where was it sold?
US Nationwide.
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 Sterile Compounding Center
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.8 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.4 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg recalled | Nephron Sterile Compounding Center | Sterility | 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 |