FDA Recall D-1175-2017
Genentech, Inc. · South San Francisco, CA
Class I — life-threatening Terminated 493 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1175-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2017-09-05
- Classified by FDA Center
- 2017-12-01
- FDA published
- 2017-09-27
- Terminated
- 2019-01-11
- Recalling firm
- Genentech, Inc.
- Firm location
- South San Francisco, CA