Cathflo Activase Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 50242-041
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Cathflo Activase (NDC 50242-041). A significant event, classified as Class II, was initiated on May 20, 2024 by Genentech, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase."
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
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
May 20, 2024
Jun 05, 2024
Lot:3618858 = 105,759; Lot:3618873 =90,359
Recall Profile & Regulatory Data
Event ID
94653
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Genentech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 11, 2025
Product Description
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Batch or Lot Expiration Information
Lot# : 3618858, 3618873, Exp. Date 01/31/2026
Affected Packages Involved in this Recall
50242-041-64Product
50242-041-10Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
1473 vials
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
Batch or Lot Expiration Information
Lot# 3410425
Affected Packages Involved in this Recall
50242-041-64Product
50242-041-10Product
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.
