FDA recall D-0143-2026

Otsuka ICU Medical LLC · Class II · drug

Product

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Reason for recall

Lack of Assurance of Sterility: Potential for flexible container leaks.

Distribution

Distributed Nationwide in the USA.

Key facts

Status
Ongoing
Initiation date
2025-10-27
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0143-2026