Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc...
FDA Recall #D-0591-2025 — Class II — August 4, 2025
Product Description
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.
Recalling Firm
PFIZER INC — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15,750 vials
Distribution
U.S. Nationwide
Code Information
Lot #: LH2671, Exp. 11/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated