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Recall Observatory FDA recall evidence

Drug product

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

D-0143-2026

October 27, 2025

Class II

Product summary

Firm
Otsuka ICU Medical LLC
Event
Event 97841
Status
Ongoing
Classification
Class II
Quantity
509,360 100 mL bags
Official record key
drug-enforcement:D-0143-2026

Official wording

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

Code information: Lot # 1029921, Exp Date: 28 February 2027

Distribution pattern: Distributed Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility