FDA MedWatch – Sodium Bicarbonate Injection USP, 8.4%, 50 mEq/50 mL Vial by Exela Pharma Sciences:

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

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy 

ISSUE: Exela Pharma Sciences (Exela) is expanding their recall, adding 14 lots to the ongoing voluntary recall of 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. All the recalled lots are listed in the recall announcement, with the additional 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 63 total recalled lots (which includes more than 2.7 million vials), Exela has received five 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 14 lots. There have been no reports of sterility failures to date with any of the 63 lots.

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

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

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
• Customers that have the recalled product should discontinue use, segregate the recalled product, submit a recall stock response form to the company (even if there is no product to return), and hold the product until shipment instructions are provided by the company.
• Customers with questions regarding this recall can contact the company.

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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