FDA-Drug2025-11-05Class II
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Otsuka ICU Medical LLC
Hazard
Lack of Assurance of Sterility: Potential for flexible container leaks.
Sold states
Distributed Nationwide in the USA.
Affected count
509,360 100 mL bags
Manufactured in
3900 Howard Ln, N/A, Austin, TX, United States
Products
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0143-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief