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: 6

Recalling firm
Fresenius Kabi USA, LLC
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
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/3f89e85b-77fb-49bd-a3cb-7db4857c8d7c