September 06, 2017

Sterile Water for Injection packaged with Activase® 100 mg may be cracked or chipped at the neck of the vial and leaking.

Please be advised that Genentech has issued a voluntary recall of Activase® (alteplase) 100 mg vial.

According to Genentech, this recall has been initiated due to complaints of Sterile Water for Injection vials manufactured by Hospira, a Pfizer company. The vials of Sterile Water for Injection are packaged with Activase® (alteplase) 100 mg, and may be cracked or chipped at the neck of the vial and leaking.

Use of the impacted Sterile Water for Injection may be associated with adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infection.

Activase® 100 mg vial

Anyone with an existing inventory of affected Activase 100 mg lots should call the FedEx Supply Chain at 877-674-2081 to affect the RGA process.