D-0079-2023 Class I Terminated
FDA drug recall D-0079-2023 was initiated by Exela Pharma Sciences LLC on Nov 28, 2022 and is designated Class I. Reason for recall: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. The recall status is terminated (terminated Oct 10, 2025). Affected quantity: 489,600 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 28, 2022
- Termination Date
- Oct 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 489,600 vials
Product Description
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.
Distribution Pattern
Nationwide within the United States
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0079-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026