Home / Recalls / Exela Pharma Sciences LLC / D-0303-2025

D-0303-2025 Class II Ongoing

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

Recall Details

Product Type: Drugs
Report Date: April 2, 2025
Initiation Date: March 7, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 103,950 vials

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

Lots: 10006417 and 10006418, Exp. 11/30/2026

Other recalls by Exela Pharma Sciences LLC

D-0620-2025 Class II — 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenou (July 30, 2025)
D-0117-2024 Class I — Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Singl (October 18, 2023)
D-0116-2024 Class I — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Sing (October 18, 2023)
D-0118-2024 Class I — ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL (October 18, 2023)
D-0079-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (November 28, 2022)
D-0080-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (November 28, 2022)
D-0023-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (October 4, 2022)
D-0022-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (October 4, 2022)
D-0369-2022 Class II — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx (January 11, 2022)
D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx o (May 5, 2020)