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

FDA recall notice · announced March 19, 2025 · Nephron Sterile Compounding Center

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: US Nationwide.
Lot/code information: Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Quantity: 4,190 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0257-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.