Fresenius Kabi Usa, Llc: 0.9% Sodium Chloride Injection, Usp 0.9% (450 Mg Per
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection (a saline solution used in medical settings) because the company cannot guarantee the product is sterile. The recall affects batches distributed nationwide, Alaska, and Puerto Rico. This is a Class II recall, meaning use of the product could cause serious adverse health consequences or death.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
- 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/5aff71bb-79e1-469f-ae9e-c927d7b1d2c8