Genentech, Inc. 2024-06-05 Health serious FDA
Health · FDA · Recall #FDA-D-0509-2024
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA… Recall
Issued June 5, 2024 · Genentech, Inc.
In June 2024, Genentech, Inc. recalled the Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
What you should do
- 1 Stop using Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Genentech, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Genentech, Inc.
- Category
- Health
- Recall date
- June 5, 2024
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0509-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Genentech, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.