Product: Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reason for recall: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Recall initiated: 20240520
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated