Status
Terminated
Drug Enforcement D-0257-2025
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Classification
Class II
Report Date
March 19, 2025
Termination Date
August 14, 2025
Product Information
- 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
- Product quantity
- 4,190 bottles
- Reason for recall
- Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Address
-
4500 12th Street Ext
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0257-2025
- Event ID
- 96419
- Recall initiation date
- February 10, 2025
- Center classification date
- March 7, 2025
- Code info
- Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
- More code info
- —