Exela Pharma Sciences, LLC is recalling certain lots of Sodium Bicarbonate Injection due to vial breakage, the U.S. Food and Drug Administration said.
The product is used for treatment of metabolic acidosis. The company does not expect the recall to cause drug shortage.
The recall involves 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level. The recalled product, labeled with Exela brand and Civica brand, is packaged in a 50 mL glass vial, 20 vials per carton, with various lot numbers and expiration dates.
The Exela brand includes carton NDC: 51754-5001-5, and Vial NDC: 51754-5001-1. It can be identified by the yellow flip-top safety cap on the vial and a purple stripe on the carton.
The Civica brand with carton NDC: 72572-740-20; and Vial NDC: 72572-740-1, can be identified by the yellow flip-top safety cap on the vial, and green stripe on the carton.
The product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.
The agency noted that the product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration.
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.
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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