FDA Drug recall D-1175-2017
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP a…
- FDA Drug
- Class I
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class I recall of Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP a… by Genentech, citing non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1175-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Genentech |
| Distribution | US |
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
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Identifiers
| code_info | Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Genentech
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1175-2017%22
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