Activase recalled over sterility concerns

Recall date

September 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Genentech, Inc. recalls Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water…

Recall number

D-1175-2017

FDA classification

Class I

Brand / firm

Genentech, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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