of
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL due to Defective Crimp of the Vial
Company Contact:
Meredith Teseniar (828) 341-6118 x 1017
FOR IMMEDIATE RELEASE – March 13, 2025 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below. This is a nation-wide Class I recall to the consumer level. Defective crimp in certain instances may lead to the stopper to dislodge from the vial when the fliptop is being removed.
| Product | Strength | Vial Size |
| 8.4% Sodium Bicarbonate Injection, USP | 50 mEq/50 mL | 50 mL Single Dose Vial |
Risk Statement: The defective crimp on the vial may expose the drug product to the environment and could potentially impact the sterility and purity of the product. There are no known sterility failures or adverse health events as of this date. There are no known injuries to any personnel.
8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1, Figure 1).
The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots include the following lot numbers and expiration dates:
| Brand | Lot | Expire Date |
| Exela | 10006417 | 10/2026 |
| Exela | 10006418 | 10/2026 |
Product was distributed nationwide to wholesalers, distributors, and health systems between February 5, 2025, and February 20, 2025.
Exela is notifying its customers by phone, e-mail and certified mail if necessary and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should immediately discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.
Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email at 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.
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 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.