Roche’s Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, which were co-packaged with sterile water for injection, to the hospital level because of sterility issues, according to a Sep. 6, 2017 press release by FDA. The vials of sterile water for injection that were packaged with Activase 100 mg may be cracked or chipped at the neck of the vial and leaking. These vials were manufactured by Hospira, a Pfizer company which the drugmaker acquired for $17 billion in 2015.
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 the use of impacted sterile water for injection.
