Class II
Terminated
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
This recall has been terminated (originally issued March 19, 2025).
- Recall Initiated
- February 10, 2025
- Posted
- March 19, 2025
- Recall Number
- D-0257-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,190 bottles
- Firm Location
- West Columbia, SC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Distribution
US Nationwide.
Lot / Code Info
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
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