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FDARecalled Apr 15, 2026 · #D-0428-2026

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...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility Classification: Class II Distribution: US Nationwide , Alaska, and Puerto Rico.

Product details

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.
Type
Drugs
Manufacturer
Fresenius Kabi USA, LLC
Model numbers
UPCs