0.9% Sodium Chloride Injection USP recall: Sterility Concern
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Why was 0.9% Sodium Chloride Injection USP recalled?
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
- Product
- 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
- Recalling firm
- B BRAUN MEDICAL INC
- Quantity
- 187,656 containers
- Distribution
- USA Nationwide
- Recall date
- July 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)