0.9% Sodium Chloride Injection, Usp 0.9% (450 Mg Per 50 Ml) (9 Mg Per Ml) 50 Ml, Rx Only, Fresenius Kabi Usa, LLC ("fresenius Kabi"), Lake Zurich, Il 60047, Unit Of Use Ndc: 65219-466-05, Unit Of Sale

Recalling firm
Fresenius Kabi USA, LLC
Product
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Reason
Lack of Assurance of Sterility
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-03-11
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide , Alaska, and Puerto Rico.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/a80f8714-b94a-49d0-8da9-49739dec59b8