FDA Drug recall D-0655-2022
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
- FDA Drug
- Class II
- terminated
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20 by B Braun Medical, citing lack of sterility assurance: leaking bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0655-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-25 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Reason
Lack of sterility assurance: leaking bags
Identifiers
| ndc | 0264-7800-00 |
|---|---|
| ndc | 0264-7800-10 |
| ndc | 0264-7800-20 |
| ndc | 0264-7802-00 |
| ndc | 0264-7802-10 |
| code_info | Lot #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.