FDA recall D-0369-2022

Product

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-01-11

Report date

2022-01-19

Termination date

2022-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenoir, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0369-2022