#USA #Lake Forest #Potassium Chloride #ICU Medical #Drug Recall

ICU Medical's Voluntary Recall of Potassium Chloride Injections

In a significant move this week, ICU Medical, Inc. has announced a voluntary recall affecting their Potassium Chloride Injection products. The recall specifically targets one lot each of the 20 mEq and 10 mEq versions due to mislabeling concerns that could have serious consequences for patients.

Background of the Recall

The recall was initiated after ICU Medical received a complaint regarding the labeling of the injections. The affected 100 mL bags, which contain Potassium Chloride, were incorrectly labeled, presenting the 10 mEq dosage instead of the actual 20 mEq contained within the I.V. bags. Such mislabeling can create a significant risk if healthcare providers rely on the inaccurate 10 mEq labeling for calculating dosages, potentially leading to potassium overdoses.

Inadequate monitoring of dosage due to this error can pose life-threatening risks, particularly to vulnerable populations like premature infants and patients with existing heart or kidney conditions. Patients at risk may experience severe hyperkalemia, which can result in muscle dysfunction, paralysis, hypotension, and even fatal cardiac events.

Detailed Product Information

The bags in question can be identified through specific National Drug Codes (NDC). The affected lot number is 1023172 with an expiration date of January 31, 2026. The mislabeling issue was confined to a particular production batch, and there have been no reports of adverse effects linked to this problem thus far.

The products affected include:

• - NDC 0990-7074-26: Potassium Chloride Injection 10 mEq (mislabeled)
• - NDC 0990-7075-26: Potassium Chloride Injection 20 mEq (correctly labeled)

Healthcare professionals are advised to immediately cease using or distributing the impacted lots and to return them to their point of purchase.

Actions Taken

ICU Medical is actively notifying distributors and customers about the recall via official communication channels. The company is facilitating the return process for these products. They urge any healthcare provider who has used the inaccurately labeled injections to assess any potential health risks associated with the treatment.

Contact Information for Patients and Providers

Patients or healthcare providers who have questions regarding this recall can contact ICU Medical at:

• - Phone: 1-844-654-7780 (available Monday to Friday, 8 AM to 5 PM CST)
• - Email: [email protected]

It is essential for consumers who may have experienced issues related to the use of this affected drug product to reach out to their healthcare provider for guidance.

Conclusion

ICU Medical's proactive approach in issuing this recall reflects its commitment to patient safety and product integrity. As the healthcare industry continues to navigate labeling challenges, it is crucial for all stakeholders to remain vigilant, ensuring the accurate dispensing of medication to protect patient health.