Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou
Recalled April 2, 2025 · FDA recall D-0303-2025 · Exela Pharma Sciences
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
103,950 vials
Sold at
Nationwide
Description
Lack of Assurance of Sterility
Product
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Manufacturer(s)
Exela Pharma Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →