Drug product
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
D-0353-2025
Product summary
- Event
- Event 96605
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32,256 Bottles
- Official record key
drug-enforcement:D-0353-2025
Official wording
Reason: Presence of Particulate Matter
Code information: Lot # J4K936, Exp 7/31/2027
Distribution pattern: Product was distributed to 12 distributors who may have further distributed the product nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter