Otsuka ICU Recalls Potassium Chloride for Mislabeling

Otsuka ICU Medical LLC has announced a voluntary recall of a specific lot of Potassium Chloride Injection due to a labeling error. The overwrap of the 20 mEq Potassium Chloride Injection is incorrectly labeled as 10 mEq, posing a risk of overdose.

Affected Products:

• Product: Potassium Chloride Injection 20 mEq
• NDC: 0990-7077-14
• Lot Number: 1030613
• Expiration Date: 09-30-2026
• Distributed: May 23, 2025 - August 26, 2025

Reason for Recall:

The recall is due to a mislabeling issue where the overwrap of the 20 mEq injection is labeled as 10 mEq. This can lead to an overdose, causing hyperkalemia, which may result in severe health risks such as muscle weakness, cardiac dysrhythmias, or even cardiac arrest.

What Consumers Should Do:

• Stop using the affected product immediately.
• Return the product to the place of purchase.
• Contact Sedgwick at 1-888-566-2363 for return labels and assistance.
• Report any adverse reactions to the FDA's MedWatch program.

Otsuka ICU Medical LLC has not received any reports of adverse events related to this issue so far. For further inquiries, consumers can contact Otsuka ICU Medical LLC at 1-844-654-7780 or via email at [email protected].