Exela Pharma Sciences 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. The additional lots were distributed October 26, 2021, through April 25, 2022.
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.
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