Recall: D-0620-2025

Class II - Potentially Harmful

Class IIClassification

2025-07-30Initiated

OngoingStatus

Exela Pharma Sciences LLCFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.