Sodium Bicarbonate Injection – USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton by Exela Pharma Sciences: Recall – Due to Vial Breakage
By Luc Puis
Exela Pharma Sciences is recalling 49 lots of Sodium Bicarbonate Injection – USP, 8.4%, 50 mEq/50 mL vial, 20count carton, because the product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration.
Exela has received five (5) reports of flying glass injuring the skin, eye, and/or other parts. There have been no reports of sterility failures.
This recall is not expected to cause a drug shortage.
The product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021, and August 10, 2022.
The product is used for the treatment of metabolic acidosis.
Exela is notifying its customers by e-mail and certified mail and is arranging for the return and replacement of all recalled products directly to the company. Customers that have the product, which is being recalled, should discontinue use, segregate the recalled product, submit a recall stock response form to the company, and hold the product until shipment instructions are provided. Customers with questions regarding this recall can contact the company. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
