0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation ...
FDA Recall #D-0353-2025 — Class II — March 31, 2025
Product Description
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
Reason for Recall
Presence of Particulate Matter
Recalling Firm
B. Braun Medical Inc — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
32,256 Bottles
Distribution
Product was distributed to 12 distributors who may have further distributed the product nationwide.
Code Information
Lot # J4K936, Exp 7/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.