Recall D-0424-2026

US Class II Ongoing · initiated 2026-03-11

Recalling firm

Fresenius Kabi USA, LLC, IL

Product

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Reason for recall

Lack of Assurance of Sterility

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