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
Reported: March 19, 2025 Initiated: February 10, 2025 #D-0257-2025
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 4,190 bottles
- Distribution
- US Nationwide.
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 4,190 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 19, 2025. Severity: Moderate. Recall number: D-0257-2025.
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