Drug product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
D-0296-2026
Product summary
- Event
- Event 98178
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 125,496 bottles
- Official record key
drug-enforcement:D-0296-2026
Official wording
Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Code information: Lot #: G171359, expiry: 05/31/2027
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter