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: 50242-0

FDA recall notice · announced September 27, 2017 · Genentech

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Quantity: 16,882
Status: Terminated
Products in this recall event:
- 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 DN (D-1175-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.