Otsuka ICU Medical LLC Announces Recall of Potassium Chloride Injection
Otsuka ICU Medical LLC understands the critical importance of patient safety in healthcare. That's why the company has initiated a voluntary recall for a specific lot of Potassium Chloride Injection. This recall arises from a labeling error that could potentially confuse healthcare providers and lead to significant health risks.
Details of the Recall
The recall specifically involves the 20 mEq Potassium Chloride Injection, designated with NDC 0990-7077-14. The lot number involved in the recall is 1030613, which is set to expire on September 30, 2026. What makes this recall particularly concerning is that the overwrap label incorrectly identifies the product as the 10 mEq Potassium Chloride Injection, with NDC 0990-7074-26. Although the correct dosage is clear on the bag itself, it's obscured when the 10 mEq overwrap remains in place.
Reason for the Recall
This discrepancy was identified during a routine quality inspection, highlighting the importance of ongoing vigilance in manufacturing practices. Otsuka ICU Medical LLC takes full responsibility for ensuring their products are accurately labeled and safe for use. As a result of this issue, the company is taking all necessary steps to prevent further incidents.
Action Steps for Healthcare Professionals
If you are a healthcare provider who has received the mislabeled product, it is imperative that you take the necessary actions to ensure patient safety. Otsuka ICU Medical encourages affected individuals to follow the outlined procedures in the recall notification. This includes examining your inventory for the affected lot and discontinuing use immediately if found. Reporting any adverse events or side effects related to this product is crucial.
Company Commitment to Safety
Otsuka ICU Medical LLC is committed to maintaining the highest standards of quality and safety in all of its products. The company is actively working with healthcare providers to ensure that all necessary corrective measures are taken promptly. The health and well-being of patients remain a top priority for Otsuka ICU Medical, and they are dedicated to rectifying the situation as swiftly as possible.
Frequently Asked Questions
What is the reason for Otsuka's recall?
The recall was issued due to a labeling error where a lot of 20 mEq Potassium Chloride Injection was incorrectly labeled as 10 mEq.
How can healthcare professionals report affected products?
Healthcare professionals should follow the steps provided in the recall notification for reporting any affected inventory and potential adverse events.
What is the expiration date of the recalled product?
The affected lot of the recalled product is set to expire on September 30, 2026.
Will affected healthcare providers receive support?
Yes, Otsuka ICU Medical LLC is dedicated to assisting healthcare providers to manage the recall effectively.
How important is it to report side effects?
Reporting any adverse events related to the product is crucial for patient safety and helps the company take corrective actions.
