FDA-Drug2024-06-05Class II
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Genentech, Inc.
Hazard
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Sold states
Nationwide within the United States
Affected count
Lot:3618858 = 105,759; Lot:3618873 =90,359
Manufactured in
1 Dna Way Bldg 5, South San Francisco, CA, United States
Products
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2024Don't want to check this manually?
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