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Recall Observatory FDA recall evidence

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

February 10, 2025

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility