Drug recall D-0080-2023
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Reason for recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Lots and codes
Lot: P0001490 Exp. 12/2023
Recall details
- Recalling firm
- Exela Pharma Sciences LLC, Lenoir, NC
- Quantity
- 37,320 vials
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 28, 2022
- Terminated
- October 10, 2025
Related products
- NDC 72572-740 Sodium Bicarbonate · Sodium Bicarbonate 84 mg/mL · Civica