8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit ...
FDA Recall #D-0234-2024 — Class I — December 21, 2023
Product Description
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (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
21200 Cartons
Distribution
Nationwide in the USA and Puerto Rico.
Code Information
Lot HA7295, EXP 03/01/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated