FDAFDA · Food and drugs·Recall number D-0181-2026
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
Published November 26, 2025 · Recall initiated: October 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Otsuka ICU Medical LLC
- Distributor
- US Nationwide.
- Lot
- Lot # 1030613, Exp Date: 09/30/2026
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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