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
D-0257-2025
Product summary
- Event
- Event 96419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,190 bottles
- Official record key
drug-enforcement:D-0257-2025
Official wording
Reason: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Code information: Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility