Recall of Activase (alteplase) 100mg by Genentech due to lack of sterility assurance

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ISSUE: Genentech 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.  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.

BACKGROUND: Activase is supplied directly to hospitals and used in a hospital setting. Activase is indicated for treating patients with acute ischemic stroke (AIS), which is caused by a blood clot in the brain’s blood vessels, for treating an acute myocardial infarction (AMI), also known as a heart attack and to break apart an acute massive pulmonary embolism (PE), which is a large blood clot lodged in the blood vessels of the lung. Activase is supplied as a sterile, lyophilized powder in 100 mg vials without vacuum. Each 100 mg Activase vial (58...

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