Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

[Posted 09/07/2017]

AUDIENCE: Pharmacy, Critical Care Medicine

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 million IU) is packaged with diluent for reconstitution (100 mL Sterile Water for Injection, USP), and one transfer device: NDC 50242-085-27. The product was distributed nationwide to hospitals.

RECOMMENDATION: Genentech is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have lots of Activase that have been recalled should stop using the product and should return the affected lots to Genentech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[09/06/2017 - Press Release - Genentech]