D-0296-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- February 4, 2026
- Initiation Date
- December 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125,496 bottles
Product Description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Reason for Recall
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Distribution Pattern
Nationwide
Code Information
Lot #: G171359, expiry: 05/31/2027