Genentech recalls lots of Activase due to lack of sterility assurance

Genentech, a subsidiary of Swiss pharma giant Roche (ROG: SIX), is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level.

The vials of Sterile Water for Injection, manufactured by Hospira, a Pfizer (NYSE: PFE) company, and packaged with Activase 100mg, may be cracked or chipped at the neck of the vial and leaking.  See press release for affected lots.

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 infections. To date, Genentech has not received reports of adverse events associated with use of impacted Sterile Water for Injection.