FDA Drugs recall ·
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only… recall
- Recall number
- D-0257-2025
- Date
- (initiated February 10, 2025)
- Company / brand
- Nephron Sterile Compounding Center LLC
4500 12th Street Ext, West Columbia, SC, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 4,190 bottles
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0257-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.