4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syrin...
FDA Recall #D-0233-2024 — Class I — December 21, 2023
Product Description
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
Reason for Recall
Presence of Particulate Matter; identified as glass
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
34000 Cartons
Distribution
Nationwide in the USA and Puerto Rico.
Code Information
Lot GX1542, Exp. 01/01/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated