Otsuka ICU Medical Recalls Lot of Sodium Chloride Injection Due to Potassium Chloride Mix-Up

Otsuka ICU Medical LLC is recalling one lot of 0.9% sodium chloride injection after a customer discovered a bag of concentrated potassium chloride inside a mislabeled overwrap. The recall involves 100-mL intravenous (IV) bags across the United States, with the affected lot number being 1042188 (NDC 0990-7984-23). The lot, which has an expiration date of October 31, 2027, may contain bags labeled as sodium chloride but actually containing potassium chloride injection 10 mEq (NDC 0990-7074-26; lot 1035181).

The mix-up poses serious risks, including potential adverse events such as muscle weakness, cardiac dysrhythmias, and even death. In particular, premature infants and individuals with cardiac arrhythmias or renal failure are at heightened risk. Otsuka has reported no adverse events related to this issue, but warns that injecting highly concentrated potassium chloride could lead to grave consequences.

The company has initiated a user-level recall, advising all healthcare facilities to identify and remove the affected product from use. Otsuka is notifying customers, including distributors, and has requested the return of all recalled products. In its announcement, the company emphasized the importance of quarantining and discontinuing use of any affected inventory.

Customers can report adverse events or quality issues related to this recall to ICU Medical Drug Safety at 1-844-654-7780 or [email protected]. Additionally, reports can be made through the FDA's MedWatch Adverse Event Reporting program.