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
D-0628-2025
Product summary
- Event
- Event 97433
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 47,148 containers
- Official record key
drug-enforcement:D-0628-2025
Official wording
Reason: Presence of Particulate Matter.
Code information: Lot #: V3K770, Exp 1/31/2026
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter