← FDA ENFORCEMENT
D-0143-2026Class II

Otsuka ICU Medical LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 Monitoring
Reason 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. 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. Open the enforcement explorer →