February 2025 FDA Recall Drug by Nephron Sterile Compounding Center Llc
D-0257-2025 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Nephron Sterile Compounding Center Llc on February 10, 2025 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0257-2025

Reason for Recall
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Initiated
02-10-2025
Reported
03-19-2025
Quantity
4,190 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96419
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Nephron Sterile Compounding Center LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2025
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# NA4008B, exp. date 03/03/2025
Lot# NA4005B & NA4005E, exp. date 02/20/2025