Aminophylline Injection, Solution
FDA Recall NDC 0409-5921
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 Aminophylline (NDC 0409-5921). A significant event, classified as Class II, was initiated on Sep 27, 2022 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Sep 27, 2022
Oct 12, 2022
103,150 10 mL vials
Recall Profile & Regulatory Data
Event ID
90903
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in the United States and Puerto Rico.
Termination Date
Aug 21, 2024
Product Description
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Batch or Lot Expiration Information
Lot# Lot: 30-137-DK Exp. 1 DEC. 2022
Affected Packages Involved in this Recall
0409-5921-16Product
0409-5921-01Product
0409-5922-16Product
0409-5922-01Product
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.
