Recall Enforment Report D-0080-2023

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Exela Pharma Sciences LLC, originally initiated on 11-28-2022 for the 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. The product was recalled due to defective container: complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0080-202311-28-202212-21-2022Class I37,320 vials8.4% 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.Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.Ongoing
D-0079-202311-28-202212-21-2022Class I489,600 vials8.4% 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.Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
51754-5001Sodium Bicarbonate Sodium BicarbonateInjection, SolutionIntravenousExela Pharma Sciences, LlcHuman Prescription Drug
51754-5002Sodium Bicarbonate Sodium BicarbonateInjection, SolutionIntravenousExela Pharma Sciences, LlcHuman Prescription Drug
51754-5011Sodium Bicarbonate Sodium BicarbonateInjection, SolutionIntravenousExela Pharma Sciences, LlcHuman Prescription Drug
51754-5012Sodium Bicarbonate Sodium BicarbonateInjection, SolutionIntravenousExela Pharma Sciences, LlcHuman Prescription Drug
72572-740Sodium Bicarbonate Sodium BicarbonateInjection, SolutionIntravenousCivicaHuman Prescription Drug