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)
Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Recall initiated: 20250730
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated