0.9% Sodium Chloride Injection, Usp 900 Mg Per 100 Ml (9 Mg Per Ml) 500 Ml In A Single Dose Freeflex Bag, 500 Ml X 20, Manufactured For: Fresenius Kabi Usa, LLC ("fresenius Kabi"), Il 60047, Unit Of U

Recalling firm
Fresenius Kabi USA, LLC
Product
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
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/9fa9edc4-1f3a-4e49-82e6-cd00a7c4c424