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FDAOctober 27, 2025drug

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility: Potential for flexible container leaks.

What to do

FDA enforcement status: Ongoing

Brands named

otsuka icu medicalotsukaotsuka icu

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 — Recall Details · AllClear