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Recall Observatory FDA recall evidence

Drug product

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

D-0181-2026

October 29, 2025

Class I

Product summary

Firm
Otsuka ICU Medical LLC
Event
Event 97888
Status
Ongoing
Classification
Class I
Quantity
Unavailable
Official record key
drug-enforcement:D-0181-2026

Official wording

Reason: 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

Code information: Lot # 1030613, Exp Date: 09/30/2026

Distribution pattern: US Nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error