Class IIReported 2025-09-17

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)

Reason for Recall

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

Recall Number

D-0620-2025

Classification

Class II

Status

Ongoing