Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection, USP, after a customer found a bag of concentrated potassium chloride inside an outer wrap labeled as saline, according to the company's recall notice. The recall covers lot 1042188 (NDC 0990-7984-23), sold as 100 mL flexible containers with an expiration date of Oct. 31, 2027. The company announced the action on Sept. 17 and said it has received no reports of adverse events.
The product is a hospital IV fluid, not a consumer item, and the recall extends to the user level, meaning the hospitals, clinics, and other facilities that stock and give it to patients. According to the notice, some bags in the lot may carry a saline overwrap while the bag inside is Potassium Chloride Injection 10 mEq (NDC 0990-7074-26), lot 1035181.