Exela Pharma Sciences is recalling an additional 14 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50mEq/50 mL vial, 20-count carton. In total, the Company is recalling 63 lots of the product due to the potential for vial breakage and flying glass when pressurized while preparing the product for administration.
The full list of recalled lots is available here. The recalled product was distributed between October 26, 2021 and August 10, 2022.
Sodium Bicarbonate Injection is indicated for the treatment of metabolic acidosis. 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.
The additional lots were not part of the initial recall announcement as they did not appear to be impacted. However, during a recent inspection of retained product, 1 vial did show breakage, prompting the addition of these lots to the on-going recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Exela Pharma Sciences, LLC expands voluntary nationwide recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-count carton due to vial breakage UPDATED. News release. November 28, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50