Home / Recalls / Exela Pharma Sciences LLC / D-0080-2023

D-0080-2023 Class I Terminated

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0080-2023 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: 37,320 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: 37,320 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, 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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot: P0001490 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-0080-2023
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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