Drug recall D-1175-2017

Class I Terminated reported Sep 27, 2017

Product

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

Reason for recall

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

Lots and codes

Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.

Recall details

Recalling firm
Genentech, Inc., South San Francisco, CA
Quantity
16,882
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
September 5, 2017
Terminated
January 11, 2019