Drug recall D-0023-2023

Class I Terminated reported Nov 2, 2022

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 #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024

Recall details

Recalling firm
Exela Pharma Sciences LLC, Lenoir, NC
Quantity
148,920
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
October 4, 2022
Terminated
October 10, 2025

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