Genentech, Inc. recalls Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Recalled June 5, 2024 · FDA recall D-0509-2024 · Genentech
Hazard
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. · FDA Class II
Units
Lot:3618858 = 105,759; Lot:3618873 =90,359
Sold at
Nationwide within the United States
Description
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Product
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Manufacturer(s)
Genentech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →