Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10
Recalled April 15, 2026 · FDA recall D-0433-2026 · Fresenius Kabi USA
Hazard
Lack of Assurance of Sterility · FDA Class II
Sold at
US Nationwide , Alaska, and Puerto Rico.
Description
Lack of Assurance of Sterility
Product
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →