CLASS II Drug recall · Reported 5 Jun 2024 · FDA Enforcement Report
Cathflo activase (Alteplase), 2mg vials recalled by Genentech
Genentech is recalling Cathflo activase (Alteplase), 2mg vials, distributed nationwide in the US. The recall was initiated on 20 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0509-2024
- FDA event ID
- 94653
- Recalling firm
- Genentech, South San Francisco, CA
- Brand
- Cathflo Activase
- Manufacturer
- Genentech, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2024
- FDA classified
- 24 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 20 May 2024 | Recall initiated by company | |
| 24 May 2024 | Classified by FDA | +4 days |
| 5 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Which lots are affected?
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS III | Susvimo (ranibizumab injection), 100mg/mL recalled by GenentechSusvimo | Genentech | Other | Nationwide |
| Drug | CLASS II | Xolair (omalizumab) Injection, 150 mg/, 1 prefilled syringe recalledXolair | Genentech | Potency & Assay | Nationwide |
| Drug | CLASS III | Evrysdi (risdiplam) for oral solution, 60 mg recalled by Genentech | Genentech | Other | Nationwide |
| Drug | CLASS III | Klonopin (clonazepam) recalled by Genentech | Genentech | Other | Nationwide |
| Drug | CLASS I | Activase (alteplase), 100 mg (58 million IU) recalled by Genentech | Genentech | Foreign Material | Nationwide |
Other Alteplase recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | cathflo activase (Alteplase) 2 mg recalled by Cardinal HealthCathflo Activase | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Alteplase 1 mg/mL in syringe, Made by: Enterprise Pharmacy recalled | CMC Enterprise Pharmacy | Sterility | NC |
| Drug | CLASS II | Alteplase, Sdpf - Syringe, 1/2") 1000mcg/ML Injectable recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |