Recalling firm
Otsuka ICU Medical LLC
Product type
Drug
Status
Ongoing
Report date
2025-11-05
Distribution
Distributed Nationwide in the USA.
Firm state
TX
Product quantity
509,360 100 mL bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Product description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Code / lot info
Lot # 1029921, Exp Date: 28 February 2027
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.