D-1175-2017 Class I Terminated
FDA drug recall D-1175-2017 was initiated by Genentech, Inc. on Sep 5, 2017 and is designated Class I. Reason for recall: Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. The recall status is terminated (terminated Jan 11, 2019). Affected quantity: 16,882.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 27, 2017
- Initiation Date
- Sep 5, 2017
- Termination Date
- Jan 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,882
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1175-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026