Recall: D-0428-2026
Class II - Potentially Harmful
Class IIClassification
2026-03-11Initiated
OngoingStatus
Fresenius Kabi USA, LLCFirm
Product
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Reason
Lack of Assurance of Sterility
Distribution
US Nationwide , Alaska, and Puerto Rico.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.