Exela Pharma Sciences LLC: Drug Recall

Recall #D-0620-2025 · 07/30/2025

Class II: Risk

Recall Details

Recall Number
D-0620-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Exela Pharma Sciences LLC
Status
Ongoing
Date Initiated
07/30/2025
Location
Lenoir, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Reason for Recall

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

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)

Distribution Pattern

Nationwide in the USA

Other Recalls by Exela Pharma Sciences LLC

View all recalls by Exela Pharma Sciences LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.