Class I
Ongoing
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
This recall is currently active, issued November 26, 2025. It was issued by Otsuka Icu Medical Llc.
- Company
- Otsuka Icu Medical Llc
- Recall Initiated
- October 29, 2025
- Posted
- November 26, 2025
- Recall Number
- D-0180-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 21,696 50mL flexible containers
- Firm Location
- Austin, TX, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
US Nationwide.
Lot / Code Info
Lot # 1030613, Exp Date: 09/30/2026
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