Home / Recalls / Exela Pharma Sciences LLC / D-0022-2023

D-0022-2023 Class I Terminated

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

Recall Details

Product Type
Drugs
Report Date
November 2, 2022
Initiation Date
October 4, 2022
Termination Date
October 10, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,123,040 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

Lot # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024.

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-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-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)