Last Updated on October 10, 2024 by The Health Master
Drug recall:
Exela Pharma Sciences, LLC (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton, to the consumer level.
Risk Statement:
The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration.
Exela has received five (5) reports of flying glass injuring the skin, eye, and/or other parts. There have been no reports of sterility failures.
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, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).
The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
All the above-listed lots are supplied in 20-count cartons only. This recall is not expected to cause a drug shortage.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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