May 2024 FDA Recall Cathflo Activase by Genentech, Inc.
D-0509-2024 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Genentech, Inc. on May 20, 2024 for the product Cathflo Activase. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0509-2024
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
05-20-2024
06-05-2024
Lot:3618858 = 105,759; Lot:3618873 =90,359
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Genentech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
08-11-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
