Why it was recalled
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
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
Lot numbers, UPCs & expiration codes
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0257-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 10, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 4,190 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-0257-2025, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 96419
- Address
- 4500 12th Street Ext
- Code information
- Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
- Postal code
- 29172-3025
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0257-2025
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 4,190 bottles
- Termination date
- Aug 14, 2025
- Reason for recall
- Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Feb 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2025