Sodium Chloride Injection 9% recall
FDA recall D-0257-2025 · initiated Feb 10, 2025
Nephron Sterile Compounding Center LLC recalled Sodium Chloride Injection 9% in Feb 2025 — an FDA Class II recall (D-0257-2025) because Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,190 bottles
Details
- 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
- Recalling company
- Nephron Sterile Compounding Center LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Feb 10, 2025
- FDA report date
- Mar 19, 2025
Frequently asked
- Was Sodium Chloride Injection 9% recalled?
- Nephron Sterile Compounding Center LLC recalled Sodium Chloride Injection 9% in Feb 2025 — an FDA Class II recall (D-0257-2025) because Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sodium Chloride Injection 9% recalled?
- Per the FDA enforcement record, the reason for recall D-0257-2025 was: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
- Is a recalled Sodium Chloride Injection 9% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sodium Chloride Injection 9% are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0257-2025.