0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 6...
FDA Recall #D-0143-2026 — Class II — October 27, 2025
Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Recalling Firm
Otsuka ICU Medical LLC — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
509,360 100 mL bags
Distribution
Distributed Nationwide in the USA.
Code Information
Lot # 1029921, Exp Date: 28 February 2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated