Last Updated on December 7, 2022 by The Health Master
FOR IMMEDIATE RELEASE – Exela Pharma Sciences, LLC, (Exela) is expanding its 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.
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 the skin, eyes, and/or other parts which could result in either temporary or permanent injury.
Within the sixty-three (63) total recalled lots (which include more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring the skin, eyes, 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.
The product is used for the 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) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1).
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
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