Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
cathflo activase (Alteplase)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
Affected NDC
50242-0041-64
Compare with the code on your package — it is the most precise check available.
Drug: Alteplase
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cathflo Activase Alteplase NDC 50242-0041 |
2.2 mg/2mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Genentech, Inc. | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 50242-041-64
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0476-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alteplase recalls
See all
Class II · Moderate risk
Alteplase 1 mg/mL 1 mL in 10 mL syringe
Lack of sterility assurance.
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Alteplase
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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