FDA Drug recall D-0491-2025
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…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of 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… by B Braun Medical, citing lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0491-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-16 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
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.
Reason
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Identifiers
| ndc | 0264-7800-00 |
|---|---|
| ndc | 0264-7800-10 |
| ndc | 0264-7800-20 |
| ndc | 0264-7802-00 |
| ndc | 0264-7802-10 |
| code_info | Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0491-2025%22
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