FDA Drug recall D-0638-2024
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09
- FDA Drug
- Class I
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class I recall of 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09 by B Braun Medical, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0638-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-24 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Reason
Presence of Particulate Matter
Identifiers
| ndc | 0264-7800-09 |
|---|---|
| code_info | Lot #: J2L763, J2L764, Exp: 31 March 2025 |
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-0638-2024%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.