Genentech, Inc. recalls Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water
Recalled September 27, 2017 · FDA recall D-1175-2017 · Genentech
Hazard
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. · FDA Class I
Units
16,882
Sold at
Nationwide in the USA
Description
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
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
Manufacturer(s)
Genentech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →