Lenoir, North Carolina -based Exela Pharma Sciences, LLC has expanded its recall of Sodium Bicarbonate Injection due to vial breakage to include more lots, the U.S. Food and Drug Administration said.
The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton.
In early October, the company called back 49 lots of Sodium Bicarbonate Injection , USP, 8.4%, 50 mEq/50 mL vial, 20-count carton due to vial breakage. The recall now adds 14 lots to the ongoing recall of Sodium Bicarbonate Injection. A total of 63 lots are now being recalled to the consumer level, which includes more than 2.7 million vials.
The vials are labeled with Exela brand and Civica brand. The additional lots were distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and April 25, 2022. The recall is not expected to cause drug shortage.
According to the agency, 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.
The recall was initiated after Exela received five reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures to date with any of the 63 lots.
Customers are asked to discontinue use, segregate the recalled product, submit a recall stock response form to Exela, and hold the product until shipment instructions are provided by Exela.
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