Otsuka ICU Medical LLC
Austin, TX, United States
3
Total Recalls
2
Class I Recalls
3
Ongoing Recalls
Recalls by Otsuka ICU Medical LLC
FDA Drug
Class I
Ongoing
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
October 29, 2025
Otsuka ICU Medical LLC
FDA Drug
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
October 29, 2025
Otsuka ICU Medical LLC
21,696 50mL flexible containers units
FDA Drug
Class II
Ongoing
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
October 27, 2025
Otsuka ICU Medical LLC
509,360 100 mL bags units