#USA #Austin, Texas #Recall #Potassium Chloride #Otsuka ICU Medical

Otsuka ICU Medical LLC Issues Potassium Chloride Injection Recall

Otsuka ICU Medical LLC has announced a voluntary nationwide recall of a mislabeled lot of Potassium Chloride Injection, specifically the 20 mEq formulation. This recall is significant due to the potential health risks associated with the incorrect labeling that may confuse medical professionals and patients alike.

Background of the Recall

The affected lot, numbered 1030613, is labeled with an expiration date of September 30, 2026. The crucial misidentification on the overwrap label mislabels the product as 10 mEq instead of the correct 20 mEq dosage. This error was identified as a result of a manufacturing issue, leading to a serious concern about the possible risks of administering an incorrect dosage of potassium chloride.

Risks of Incorrect Dosage

Using the mislabeled product could have severe consequences, particularly for vulnerable populations such as premature infants and patients with specific medical conditions. If the incorrect 10 mEq overwrap is mistakenly used instead of the 20 mEq dosage printed on the product bag, there is a heightened risk of potassium chloride overdose, resulting in hyperkalemia.

Hyperkalemia and Its Dangers

Hyperkalemia can lead to serious health complications, including neuromuscular dysfunction, muscle weakness, and even cardiac arrest. Patients with underlying issues, such as chronic kidney disease or those receiving potassium-sparing diuretics, are especially at risk. It's vital for healthcare providers to be aware of this recall and ensure that the correct dosage is administered to avoid any potentially fatal consequences.

Product Details and Distribution

The affected product lot was manufactured on April 15, 2025, and was distributed across the United States from May 23, 2025, through August 26, 2025. The recall includes the following details:

• - NDC Number: 0990-7077-14
• - Product Description: Potassium Chloride Inj. 20 mEq
• - Configuration: 50mL in Flexible Container

For the recalled product, healthcare providers, and distributors are urged to cease use or further distribution immediately and return the product to the point of purchase.

Communication With Customers

Otsuka ICU Medical LLC is actively contacting its distributors and customers to inform them of this recall and the steps that need to be taken. Any affected products should be returned, and inquiries can be directed towards Sedgwick at 1-888-566-2363 for assistance with product return labels.

Health and Safety Protocols

It is essential that patients receiving potassium chloride injections are monitored continuously, particularly concerning their cardiac status and serum potassium levels. Healthcare providers should exercise caution and adhere strictly to recommended guidelines for potassium chloride injection to ensure patient safety.

Future Precautions

Otsuka ICU Medical LLC emphasizes the importance of clear communication and diligent monitoring to prevent such occurrences in the future. The company is dedicated to maintaining high standards of quality and safety in all its products. Further inquiries can be directed to Otsuka ICU Medical LLC through designated contact points for complaints, medical information, and drug safety.

Individuals experiencing any adverse reactions or quality concerns regarding this product are encouraged to report these incidents through the FDA’s MedWatch program, ensuring that such issues are documented and addressed appropriately.

Otsuka ICU Medical remains committed to delivering safe and effective healthcare solutions and will continue to provide updates as necessary regarding this recall situation.