FDA-Drug2025-11-26Class I
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
Otsuka ICU Medical LLC
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
Sold states
US Nationwide.
Affected count
21,696 50mL flexible containers
Manufactured in
3900 Howard Ln, Austin, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0180-2026Don't want to check this manually?
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