FDA recall D-0591-2025

PFIZER INC · Class II · drug

Product

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

Reason for recall

Lack of Assurance of Sterility.

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-08-04
Report date: 2025-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0591-2025