Home / Recalls / Exela Pharma Sciences LLC / D-0079-2023

D-0079-2023 Class I Terminated

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

Recall Details

Product Type
Drugs
Report Date
December 21, 2022
Initiation Date
November 28, 2022
Termination Date
October 10, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
489,600 vials

Product Description

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.

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-0303-2025 Class II — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Sing (March 7, 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-0118-2024 Class I — ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL (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-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)