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FDARecalled Apr 15, 2026 · #D-0426-2026

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...

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