Recall D-0143-2026

US Class II Ongoing · initiated 2025-10-27

Recalling firm

Otsuka ICU Medical LLC, TX

Product

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.

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