Cathflo activase recall: Sterility Concern
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Why was Cathflo activase recalled?
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
- Product
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Recalling firm
- Genentech, Inc.
- Quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Distribution
- Nationwide within the United States
- Recall date
- June 5, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)