Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase & reg; (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), 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 Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

Source: FDA Center for Drug Evaluation and Research - What's New - July 24, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news