FDAFDA · Food and drugs·Recall number D-1175-2017
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
Published September 27, 2017 · Recall initiated: September 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genentech, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States