Sodium Chloride Injection 9% recall: Sterility Concern
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC…
Why was Sodium Chloride Injection 9% recalled?
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
- Product
- Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC…
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Quantity
- 4,190 bottles
- Distribution
- US Nationwide.
- Recall date
- March 19, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)