#United States #Austin #Potassium Chloride #Otsuka ICU Medical #Sodium Chloride

Otsuka ICU Medical's Nationwide Recall of Sodium Chloride Injection

Otsuka ICU Medical LLC has announced a voluntary recall of one specific lot of its 0.9% Sodium Chloride Injection, USP, packaged in a 100 mL single-use format. This decision was made following a significant concern regarding a potential product mix-up that has raised alarm among healthcare providers and patients alike.

Understanding the Recall

The affected lot (NDC 0990-7984-23, Lot 1042188) has been identified to potentially contain the wrong product. Although the outer packaging is labeled as 0.9% Sodium Chloride Injection, the actual contents may instead be Potassium Chloride Injection, 10 mEq (NDC 0990-7074-26, Lot 1035181). This mix-up was first identified through a customer complaint, where a 10 mEq Potassium Chloride Injection was found inside the Sodium Chloride packaging during an inspection.

The significance of this issue cannot be overstated, as the unintentional injection of a highly concentrated form of potassium chloride poses a serious health risk, especially to vulnerable populations such as premature infants or individuals with underlying health conditions. Symptoms from inadvertent potassium chloride administration can include severe neuromuscular dysfunction, cardiac irregularities, and potentially fatal cardiac arrest.

Health Risks

The recall is particularly urgent for specific patient groups, including:

• - Premature infants
• - Patients on long-term intravenous nutrition
• - Individuals with cardiac arrhythmias
• - Patients suffering from chronic renal insufficiency
• - Those on potassium-sparing diuretics

These populations are at a heightened risk of experiencing adverse events like muscle weakness, ascending paralysis, confusion, hypotension, and even death from cardiac complications. As per the latest updates, Otsuka ICU Medical has not reported any adverse events related to this recall yet.

Details of the Affected Products

The specific product’s details are as follows:

• - NDC Number: 0990-7984-23
• - Lot Number: 1042188
• - Expiration Date: 31 October 2027
• - Configuration: 100 mL in flexible container

These products were manufactured on November 13, 2025, and distributed across the United States from December 30, 2025, to June 22, 2026. Healthcare facilities receiving these products are advised to check their inventories and quarantine any affected items immediately.

Steps for Healthcare Providers and Consumers

In light of these developments, Otsuka ICU Medical is proactively informing customers, including distributors, about the recall. They are urging all carry facilities to examine their stock for the affected products, halt further use, and return any recalled items.

The return process will be facilitated through customer service coordination, where Otsuka ICU Medical will provide return labels and further instructions. Additionally, any adverse effects or quality issues experienced with this product should be reported to the FDA through its MedWatch program.

Conclusion

Otsuka ICU Medical is committed to maintaining patient safety and encourages prompt action from all users of the affected Sodium Chloride injection. By ensuring all recalled products are returned and identifying potential risks early, the company aims to uphold the highest standards of healthcare.

For more details or inquiries, patients and healthcare providers can contact ICU Medical's customer service directly at 1-844-654-7780. For press inquiries, reach out to Harrison Richards at 949-366-4261.

This incident serves as a reminder of the critical importance of vigilance in pharmaceuticals and the safeguarding of patients' health through responsible practices.