FDA recall D-0638-2024
B. Braun Medical Inc · Class I · drug
Product
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Reason for recall
Presence of Particulate Matter
Distribution
Nationwide within U.S.A
Key facts
- Status
- Ongoing
- Initiation date
- 2024-07-24
- Report date
- 2024-08-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0638-2024