4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL...
FDA Recall #D-0620-2025 — Class II — July 30, 2025
Product Description
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.
Recalling Firm
Exela Pharma Sciences LLC — Lenoir, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the USA
Code Information
Lot # 10004077, Exp. 02/28/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated