Sodium Chloride Injection 9% — Class II drug recall D-0257-2025
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2025-03-19, distributed nationwide. Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
| Recall number | D-0257-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sterile Compounding Center LLC, West Columbia, SC, United States |
| Recall initiated | 2025-02-10 |
| Classified | 2025-03-07 |
| Reported by FDA | 2025-03-19 |
| Terminated | 2025-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 4,190 bottles |
| Reason classes | sterility, packaging |
| NDC | 69374-0334-50 |
| Lot numbers | NA4005B, NA4005E, NA4008B |
| Expiration dates | 2025-02-20, 2025-03-03 |
Product
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
Reason for recall
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0257-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.