Multi-event October 2022 FDA Recall Sodium Bicarbonate by Exela Pharma Sciences Llc

This Multi-event Class I drug recall was voluntarily initiated by Exela Pharma Sciences Llc on October 4, 2022 for the product Sodium Bicarbonate. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0022-2023 TERMINATED D-0023-2023 TERMINATED

Recall Number: D-0022-2023

Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Initiated
10-04-2022
Reported
11-02-2022
Quantity
2,123,040 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90956
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Exela Pharma Sciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-10-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration 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.

Affected Packages Involved in this Recall

51754-5001-5 Sodium Bicarbonate
51754-5001-4 Sodium Bicarbonate
51754-5011-4 Sodium Bicarbonate
51754-5002-5 Sodium Bicarbonate
51754-5012-4 Sodium Bicarbonate
51754-5001-1 Sodium Bicarbonate

Recall Number: D-0023-2023

Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Initiated
10-04-2022
Reported
11-02-2022
Quantity
148,920

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90956
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Exela Pharma Sciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-10-2025
Product Description About Product Description
Full technical description of the product.
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

Batch or Lot Expiration Information

Lot# : P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024