Drug recall D-0079-2023
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Reason for recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Lots and codes
Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.
Recall details
- Recalling firm
- Exela Pharma Sciences LLC, Lenoir, NC
- Quantity
- 489,600 vials
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 28, 2022
- Terminated
- October 10, 2025
Related products
- Sodium bicarbonate – drug information
- NDC 51754-5002 Sodium Bicarbonate · Sodium Bicarbonate 75 mg/mL · Exela Pharma Sciences, LLC
- NDC 51754-5001 Sodium Bicarbonate · Sodium Bicarbonate 84 mg/mL · Exela Pharma Sciences, LLC
- NDC 51754-5012 Sodium Bicarbonate · Sodium Bicarbonate 42 mg/mL · Exela Pharma Sciences, LLC
- NDC 51754-5011 Sodium Bicarbonate · Sodium Bicarbonate 84 mg/mL · Exela Pharma Sciences, LLC