Fresenius Kabi Usa, Llc: 0.9% Sodium Chloride Injection, Usp, (4,500 Mg Per
Recall Summary Fresenius Kabi is recalling 0.9% Sodium Chloride Injection (a saline solution) in 500 mL bags because the company cannot guarantee the product is sterile. The recall affects product distributed nationwide, including all states and Puerto Rico. This is a prescription-only injectable medication used in medical settings.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
- 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/b8f505a2-5405-47cc-a35c-7e30e630eeb2