Otsuka ICU Medical LLC recalls 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798
Recalled November 5, 2025 · FDA recall D-0143-2026 · Otsuka ICU Medical
Hazard
Lack of Assurance of Sterility: Potential for flexible container leaks. · FDA Class II
Units
509,360 100 mL bags
Sold at
Distributed Nationwide in the USA.
Description
Lack of Assurance of Sterility: Potential for flexible container leaks.
Product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Manufacturer(s)
Otsuka ICU Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →