FDA recall D-0628-2025
B BRAUN MEDICAL INC · Class I · drug
Product
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Reason for recall
Presence of Particulate Matter.
Distribution
U.S.A. Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2025-08-18
- Report date
- 2025-09-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Allentown, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2025