FDA-Drug2017-09-27Class I

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

Genentech, Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
16,882
Manufactured in
1 Dna Way, N/A, South San Francisco, CA, United States
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 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27

Official notice

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

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