Fresenius Kabi Usa, Llc: 0.9% Sodium Chloride Injection, Usp, 900 Mg Per
Recall Summary Fresenius Kabi USA is recalling 0.9% Sodium Chloride Injection (saline solution) in 100 mL single-dose bags because the company cannot confirm the product is sterile. The affected product has NDC number 17271-701-03 and was distributed nationwide, including Alaska and Puerto Rico. This is a Class II recall, meaning use of the product could cause serious adverse health effects or death.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
- 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/244e5fb2-103a-4c72-b91d-0ac8d86b6173