FDA recall D-0509-2024

Genentech, Inc. · Class II · drug

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.

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2024-05-20
Report date: 2024-06-05
Termination date: 2025-08-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2024