Exela Pharma Sciences LLC recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx O
Recalled September 17, 2025 · FDA recall D-0620-2025 · Exela Pharma Sciences
Hazard
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. · FDA Class II
Units
N/A
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Product
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Manufacturer(s)
Exela Pharma Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →