Class II · Moderate risk Terminated
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
What was recalled
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Recalling firm
- Genentech, Inc.
- NDC code
- 50242-041-64
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0509-2024
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
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…
Reason Lack of sterility assurance.
Class I · High risk Terminated
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for…
Reason Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk Terminated
ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE)…
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…
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