Drug product
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
D-0638-2024
Product summary
- Event
- Event 95035
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 63,444 containers
- Official record key
drug-enforcement:D-0638-2024
Official wording
Reason: Presence of Particulate Matter
Code information: Lot #: J2L763, J2L764, Exp: 31 March 2025
Distribution pattern: Nationwide within U.S.A
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter