FDA recall D-0257-2025

Nephron Sterile Compounding Center LLC · Class II · drug

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.

Distribution

US Nationwide.

Key facts

Status: Terminated
Initiation date: 2025-02-10
Report date: 2025-03-19
Termination date: 2025-08-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2025