Exela Pharma Sciences LLC: Drug Recall

Recall #D-0303-2025 · 03/07/2025

Class II: Risk

Recall Details

Recall Number: D-0303-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Exela Pharma Sciences LLC
Status: Ongoing
Date Initiated: 03/07/2025
Location: Lenoir, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 103,950 vials

Reason for Recall

Lack of Assurance of Sterility

Product Description

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4

Distribution Pattern

Nationwide

Other Recalls by Exela Pharma Sciences LLC

Class II: Risk 07/30/2025

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class I: Dangerous 10/18/2023

Presence of Particulate Matter: Silicone
Class I: Dangerous 10/18/2023

Presence of Particulate Matter: Silicone
Class I: Dangerous 10/18/2023

Presence of Particulate Matter: Silicone
Class I: Dangerous 11/28/2022

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

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.