FDA recall D-0303-2025

Product

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2025-03-07

Report date

2025-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenoir, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0303-2025