Class II · Moderate risk Terminated
Cathflo activase
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Activase
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
What was recalled
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
- Recalling firm
- Genentech, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1175-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Alteplase recalls
See all
Class II · Moderate risk Terminated
cathflo activase
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Alteplase 1 mg/mL 1 mL in 10 mL syringe
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Alteplase
Reason 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.
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