Otsuka ICU Medical recalls Potassium Chloride Inj. 10 mEq/100mL due to label error that could lead to incorrect dosing. Affected units have a specific NDC and lot number.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Otsuka ICU Medical is recalling Potassium Chloride injection products because the labels might incorrectly state a 10 mEq dose instead of 20 mEq. This could lead to incorrect dosing if used without proper verification.
The label error means the product might be misidentified as a lower dose (10 mEq) when it is actually a higher dose (20 mEq). This could cause incorrect dosing if the healthcare provider uses the product without verifying the correct strength.
Healthcare professionals using the product for medical purposes. Patients receiving treatment with this product are at risk if the label error leads to incorrect dosing.
Check for the NDC number 0990-7074-26 and lot number 1030613 on the product's overwrap label. The product is for ICU use only and expires September 30, 2026.
Check the overwrap label for the NDC number 0990-7074-26 and lot number 1030613. If present, the product may be affected.
The product has a label error that may incorrectly identify it as 10 mEq instead of 20 mEq, which could lead to incorrect dosing.
Look for the NDC number 0990-7074-26 and lot number 1030613 on the overwrap label. The product is for ICU use only and expires September 30, 2026.
The recall does not specify a remedy, so contact the manufacturer for guidance if you have the product.
We’ve drafted a message you can send Otsuka ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0181-2026 — Otsuka ICU Medical Otsuka ICU Medical Hello, I own a Otsuka ICU Medical that is covered by recall D-0181-2026 from Otsuka ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
