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

November 28, 2022

Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The additional lots were distributed October 26, 2021 through April 25, 2022.

  • 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. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts.
  • Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
  • Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-3321088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.
  • View the full recall notice on the U.S. FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciencesllc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50
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