Recall D-0426-2026

US Class II Ongoing · initiated 2026-03-11

Recalling firm

Fresenius Kabi USA, LLC, IL

Product

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.

Reason for recall

Lack of Assurance of Sterility

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