Class II
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.
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- Recall number
- D-0491-2025
- Report date
- July 2, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- B BRAUN MEDICAL INC
- Generic names
- SODIUM CHLORIDE
- Brand names
- SODIUM CHLORIDE
- Product NDCs
- 0264-7800, 0264-7802
Code and lot information
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Distribution
USA Nationwide
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.