Drug Safety Alerts

8.4 % Sodium Bicarbonate Injection Consumer-Level Recall

11/21/2022

On November 21, 2022, Exela Pharma Sciences issued an expanded consumer-level recall of 8.4 % Sodium Bicarbonate Injection products manufactured by Exela and distributed by Exela and Civica, Inc. This recall was issued due to a potential safety concern with vial breakage and flying glass while preparing the product for administration.

This could be a health hazard or safety risk to patients using product affected by this recall.

A complete list of the affected products and lot numbers is provided here.

According to Exela, it has observed breakage of one vial during the most recent inspection of the retain samples of the lots added in this expanded recall, but there have been no additional reports of injury from the field since Exela’s prior recall notice of October 4, 2022.

Exela has advised that this recall is being carried out in an abundance of caution due to a potential safety concern with the vial breakage while preparing the product for administration. The standard process of solution extraction via a syringe does not require pressurizing the vial but in some instances, the health care provider may apply pressure to the vial that can on occasion result in vial breakage.

Exela recommends that consumers contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please call Exela toll-free at 1-888-451-4321 or email recall@exela.us.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.