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

Recall Number: D-1175-2017

Firm: Genentech, Inc.

Classification: Class I

Status: Terminated

Report Date: 20170927

Initiation Date: 20170905

Termination Date: 20190111

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

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