FDA-Drug2025-11-05Class IIPROCESSING DEFECT
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Nationwide distributiondrug
Hazard
Lack of Assurance of Sterility: Potential for flexible container leaks.
Who it affects
Adults
Illnesses reported
None reported
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?
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