FDA Drug Class I — Most Serious

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

Hazard

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

Products

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 D
Brand
Genentech, Inc.
UPC
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.

Units Affected

16,882