Recall: D-0433-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-11Initiated

OngoingStatus

Fresenius Kabi USA, LLCFirm

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.

Reason

Lack of Assurance of Sterility

Distribution

US Nationwide , Alaska, and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.