FDA 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.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-11-28

Report date

2022-12-21

Termination date

2025-10-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenoir, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2023