Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Recall Number: D-0509-2024
Firm: Genentech, Inc.
Classification: Class II
Status: Terminated
Report Date: 20240605
Initiation Date: 20240520
Termination Date: 20250811
Reason for Recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Product Description
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64