ICU Medical Recalls Potassium Chloride Injection

(RTTNews) - The US Food and Drug Administration has annuonced that ICU Medical, Inc. is recalling Potassium Chloride Injection, 20 mEq and 10 mEq, citing mislabeling.

The recall involves one lot each of POTASSIUM CHLORIDE Injection bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Injection 20 mEq, to the user level.

The recall was initiated after ICU Medical received a customer complaint about POTASSIUM CHLORIDE Inj. 20 mEq bags having incorrect overwrap labels that say POTASSIUM CHLORIDE Inj. 10 mEq.

ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of POTASSIUM CHLORIDE due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place

A few 20 mEq bags were mislabeled with incorrect overwraps stating 10 mEq and displaying NDC 0990-7074-26 and 200 mEq/L. The correct lot number 1023172 and expiration date January 31, 2026 are on the primary container.

The recalled mislabeled bags include two NDC numbers: 0990-7074-26 and 0990-7075-26, both from lot number 1023172, with an expiration date of January 31, 2026. The first mislabeled product (NDC 0990-7074-26) has an overwrap label stating "POTASSIUM CHLORIDE Inj. 10 mEq," while the primary bag inside correctly states "POTASSIUM CHLORIDE Inj. 20 mEq.

The second product (NDC 0990-7075-26) has both the overwrap and the primary bag labeled correctly as "POTASSIUM CHLORIDE Inj. 20 mEq." Both products are packaged in 100 mL flexible containers.

Additionally, cases being recalled under NDC 0990-7075-26 contain 24 units of the 100 mL bags, also from lot 1023172, with the same expiration date of January 31, 2026.

ICU Medical found that some overwraps in one lot were mislabeled as 10 mEq instead of the correct 20 mEq due to a manufacturing issue. The correct 20 mEq label on the IV bag is either not visible or hard to see without removing the overwrap.

The impacted Potassium Chloride Injection (10 mEq and 20 mEq) is used to treat potassium deficiency when oral intake is not possible and comes in 100 mL bags.

The risk factors are if a healthcare provider calculates the dose based on the incorrect 10 mEq label, the patient may receive an overdose of potassium chloride.

A large overdose can cause severe hyperkalemia, leading to muscle weakness, paralysis, dizziness, confusion, low blood pressure, irregular heartbeats, or even cardiac arrest and death.

High-risk groups include premature infants, patients on long-term IV nutrition, those with heart rhythm issues, kidney problems, or those taking potassium-sparing diuretics.

So far, ICU Medical has not received any reports of adverse events related to this issue.

ICU Medical is informing customers, including distributors, about the recall. Healthcare professionals with recalled products are urged to stop using or distributing them and return them to the place of purchase.

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