Recall: D-0431-2026
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) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
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.