Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022

Summary

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:

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 ( [email protected] ) 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