Drug 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
D-1175-2017
Product summary
- Firm
- Genentech, Inc.
- Event
- Event 78088
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,882
- Official record key
drug-enforcement:D-1175-2017
Official wording
Reason: Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Code information: Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.