0.45% Sodium Chloride Injection, Usp, 1.125 Grams Per 250 Ml (4.5 Mg Per Ml), 250 Ml In A 250 Ml Freeflex Bag, Rx Only, Fresenius Kabi Usa, LLC ("fresenius Kabi"), Lake Zurich, Il 60047, Unit Of Use N
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
- 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/f1ddacfd-eb26-4937-977f-93249d354a58