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…

Recall date

July 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0620-2025

FDA classification

Class II

Brand / firm

Exela Pharma Sciences LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)