Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Vial Breakage

Company Name:
Exela Pharma Sciences, LLC
Brand Name:
Product Description:

Product Description

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial


Company Announcement

FOR IMMEDIATE RELEASE – November 28, 2022 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level. All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022.

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no complaints of vial breakage or injuries related to the additional fourteen (14) lots. There have been no reports of sterility failures to date with any of the sixty-three (63) lots.

Exela did not recall the additional fourteen (14) lots previously because they did not appear to be impacted. During the latest inspection of Exela’s retain product from the fourteen (14) lots, one (1) vial showed breakage. There have been no field reports of personal injury to date across all the sixty-three (63) lots since the recall process started. However, out of an abundance of caution, Exela is adding the 14 lots to the on-going recall.

The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).

The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

Brand Lot Expire Date
Exela P0001178 05/2023
Exela P0001298 08/2023
Exela P0001301 08/2023
Exela P0001313 08/2023
Exela P0001314 08/2023
Exela P0001317 08/2023
Exela P0001330 09/2023
Exela P0001370 10/2023
Exela P0001371 10/2023
Exela P0001372 10/2023
Exela P0001433 11/2023
Exela P0001434 11/2023
Exela P0001442 11/2023
Exela P0001443 12/2023
Exela P0001464 09/2023
Exela P0001467 12/2023
Exela P0001468 12/2023
Exela P0001469 12/2023
Exela P0001470 12/2023
Exela P0001472 12/2023
Exela P0001486 12/2023
Exela P0001495 12/2023
Exela P0001505 12/2023
Exela P0001506 12/2023
Exela P0001509 12/2023
Exela P0001510 12/2023
Exela P0001511 12/2023
Exela P0001512 12/2023
Exela P0001532 12/2023
Exela P0001560 01/2024
Exela P0001561 01/2024
Exela P0001562 01/2024
Exela P0001564 01/2024
Exela P0001566 01/2024
Exela P0001567 01/2024
Exela P0001568 01/2024
Exela P0001571 02/2024
Exela P0001572 02/2024
Exela P0001573 02/2024
Exela P0001574 02/2024
Exela P0001578 02/2024
Exela P0001579 02/2024
Exela P0001580 02/2024
Exela P0001583 02/2024
Exela P0001586 02/2024
Exela P0001587 02/2024
Exela P0001588 02/2024
Exela P0001593 02/2024
Exela P0001594 02/2024
Exela P0001610 02/2024
Exela P0001618 02/2024
Exela P0001619 02/2024
Exela P0001644 03/2024
Exela P0001645 03/2024
Exela P0001646 03/2024
Exela P0001654 02/2024
Civica P0001490 12/2023
Civica P0001497 12/2023
Civica P0001600 02/2024
Civica P0001663 03/2024

The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.

Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Initial Press Release


Company Contact Information


Product Photos