FDAHealthFebruary 10, 2025
Nephron Sterile Compounding Center LLC — 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
⚠️ Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 10, 2025
US Nationwide.
What's affected?
- 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
- Lot code
- NA4008B
Additional details
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4,190 bottles.
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