FDAHealthOctober 29, 2025
Otsuka ICU Medical LLC — 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
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 29, 2025
US Nationwide.
What's affected?
- Product
- 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
- Brand
- POTASSIUM CHLORIDE
- Lot code
- 1030613
Additional details
Lot # 1030613, Exp Date: 09/30/2026
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 21,696 50mL flexible containers.
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