Otsuka ICU Medical LLC Provisional
FDA Flags (3)
Class I RecallNov 2025
Otsuka ICU Medical LLC
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical,
Classification: Class I
Class I RecallNov 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,
Classification: Class I
Class II RecallNov 2025
Otsuka ICU Medical LLC
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798
Classification: Class II