> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Genentech Recalling 3 Activase Lots
- URL: https://www.fdaweb.com/genentech-recalling-3-activase-lots/
- Published: 2017-09-07T12:00:00.000Z
- Updated: 2026-09-14T22:47:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139570

FDA says that Genentech is recalling to the hospital level three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. An agency statement [says](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575027.htm?ref=fdaweb.com) that the vials of sterile water for injection manufactured by Pfizer’s Hospira unit and packaged with Activase 100 mg may be cracked or chipped at the neck of the vial and leaking.

“The use of impacted sterile water for injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic reactions,” FDA says. “To date, Genentech has not received reports of adverse events associated with use of impacted sterile water for injection.”

The company says it is arranging for the return of all recalled products.