Activase — Class I drug recall D-1175-2017
Terminated recall by Genentech, Inc., reported 2017-09-27, distributed nationwide. Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
| Recall number | D-1175-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech, Inc., South San Francisco, CA, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2017-12-01 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2019-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 16,882 |
| Reason classes | foreign material, sterility, packaging |
| NDC | 50242-0085-27 |
| Lot numbers | 3128243, 3141239, 3166728 |
| Expiration dates | 2018-09-30, 2019-02-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1175-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.