FDA recall D-1175-2017

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-09-05

Report date

2017-09-27

Termination date

2019-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1175-2017