⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

DrugsSource: FDA (drug) · Date: 2025-11-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Otsuka ICU Medical LLC
Product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason / hazard
Lack of Assurance of Sterility: Potential for flexible container leaks.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distributed Nationwide in the USA.
Recall initiated
2025-10-27
Code info
Lot # 1029921, Exp Date: 28 February 2027
Product quantity
509,360 100 mL bags
Voluntary mandated
Voluntary: Firm initiated
City
Austin
State
TX
Country
United States
Event id
97841
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