Exela Pharma Sciences, LLC has voluntarily recalled 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50mEq/50 mL vial, 20-count carton, due to a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration.
Sodium Bicarbonate Injection is indicated for the treatment of metabolic acidosis. The recalled lots of Sodium Bicarbonate Injection, USP, 8.4%, 50mEq/50 mL vial, 20-count carton are labeled with the 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). These products were distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022. The full list of affected products can be found here.
To date, the Company has received 5 reports of flying glass leading to injured skin, eye, and/or other parts. There have been no reports of sterility failures.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Exela Pharma Sciences, LLC issues voluntary nationwide recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton due to vial breakage. News release. Exela Pharma Sciences, LLC. October 12, 2022. Accessed October 14, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50