Recalls / Class II
Class IID-0257-2025
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
- Affected lot / code info
- Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Why it was recalled
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 4,190 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-02-10
- FDA classified
- 2025-03-07
- Posted by FDA
- 2025-03-19
- Terminated
- 2025-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0257-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.