TOPIC: 20 mEq Potassium Chloride Injection by Otsuka ICU Medical: Recall - Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: Otsuka ICU Medical is recalling for a MISLABELED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. Otsuka ICU Medical has identified this discrepancy due to a manufacturing issue. The dosage is correctly printed on the labeling affixed to the product bag which is not visible when the 10 mEq OVERWRAP is in place. This notification details the issue and the required steps for you to perform.
If the incorrect dosage on the 10 mEq overwrap is used instead of the correct 20mEq dosage printed on the product, an overdose of potassium chloride is possible. Overdose of potassium chloride can lead to hyperkalemia. Hazards of severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes.
The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025.
Otsuka ICU Medical LLC has not received reports of adverse events associated with this issue to date.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Potassium Chloride Injection 20 mEq and 10 mEq, is indicated in the treatment of potassium deficiency states, when oral replacement is not feasible.
THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K+ LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS RAPIDLY.
When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
RECOMMENDATIONS:
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All Customers, including distributors, that have product that is being recalled should stop use/further distribution, as applicable, and return to place of purchase.
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To return affected product or if you require assistance, please contact Sedgwick at 1-888-566-2363 to obtain a return label.
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