Atropine Sulfate Injection, Solution
FDA Recall NDC 0409-1630
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atropine Sulfate (NDC 0409-1630). A significant event, classified as Class I, was initiated on Dec 21, 2023 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter; identified as glass"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
December 2023 Class I Recall: Presence of Particulate Matter; identified as glass
Recall Number
Class I Ongoing
Presence of Particulate Matter; identified as glass
Dec 21, 2023
Jan 24, 2024
24400 Cartons
Recall Profile & Regulatory Data
Event ID
93681
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
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).
Batch or Lot Expiration Information
Lot# Lot GY2496, Exp 02/01/2025
Affected Packages Involved in this Recall
0409-1630-15Product
0409-1630-10Product
0409-9630-15Product
0409-9630-05Product
0409-4910-11Product
0409-4910-34Product
0409-4911-11Product
0409-4911-34Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
