FDA MedWatch – Sodium Bicarbonate Injection – USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton by Exela Pharma Sciences

TOPIC: Sodium Bicarbonate Injection – USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton by Exela Pharma Sciences: Recall – Due to Vial Breakage

AUDIENCE: Patient, Consumer, Health Professional, Pharmacy

ISSUE: 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 skin, eye and/or other parts.  There have been no reports of sterility failures.

This recall is not expected to cause drug shortage.

Product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021, and August 10, 2022.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: The product is used for treatment of metabolic acidosis.

RECOMMENDATIONS: 

• Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product 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:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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