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, I
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Otsuka ICU Medical LLC
- 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
- Reason / 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
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2025-10-29
- Code info
- Lot # 1030613, Exp Date: 09/30/2026
- Product quantity
- 21,696 50mL flexible containers
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austin
- State
- TX
- Country
- United States
- Event id
- 97888
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