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 Nd

Recalling firm
Fresenius Kabi USA, LLC
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.
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/8ec16597-eb75-4caa-9548-d3ff9f115bf9