Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Sy...
FDA Recall #D-0235-2024 — Class I — December 21, 2023
Product Description
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (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
24400 Cartons
Distribution
Nationwide in the USA and Puerto Rico.
Code Information
Lot GY2496, Exp 02/01/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated