FDA Drug recall D-0257-2025
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC…
- FDA Drug
- Class II
- terminated
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0257-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-02-10 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
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
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Identifiers
| code_info | Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Nephron Sterile Compounding Center
- Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per car…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged i…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottle…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
All Nephron Sterile Compounding Center recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.