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
Reported: September 27, 2017 Initiated: September 5, 2017 #D-1175-2017
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.
Details
- Recalling Firm
- Genentech, Inc.
- Units Affected
- 16,882
- Distribution
- Nationwide in the USA
- Location
- South San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Genentech, Inc.. Units affected: 16,882.
Why was this product recalled? ▼
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 27, 2017. Severity: Critical. Recall number: D-1175-2017.
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