FDA recall D-0620-2025

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.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-07-30

Report date

2025-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenoir, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0620-2025