What happened
Otsuka ICU Medical LLC announced a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after a customer complaint identified a potential product mix-up. Sodium chloride overwraps from lot 1042188, NDC 0990-7984-23, may contain 10-mEq Potassium Chloride Injection bags from lot 1035181. The affected lot was manufactured on November 13, 2025, distributed in the United States from December 30, 2025, through June 22, 2026, and expires October 31, 2027. The company reported no related adverse events to date. Customers and distributors were instructed to inspect inventory, quarantine and discontinue use, and return affected product.
Why it matters
From a GMP and pharmaceutical manufacturing perspective, the reported mismatch between an overwrap’s sodium chloride labeling and the potassium chloride bag inside may warrant attention to packaging and labeling controls designed to prevent product mix-ups. Detection through a customer complaint also highlights the relevance of complaint handling and lot-level traceability for identifying affected inventory. Because inadvertent administration could be fatal, prompt quarantine, discontinuation of use, customer notification, and return coordination are important elements of this recall response.
Key topics: Sodium chloride and potassium chloride product mix-up, Incorrect IV bag inside labeled overwrap, Nationwide user-level recall of lot 1042188