Genentech, a member of the Roche Group, is recalling three lots of the blood clot busting medication Activase co-packaged with sterile water for injection because the vials may be leaking from a crack or chip at the neck. Use of this product could result in adverse events including fever, chills, phlebitis, and granuloma, or more serious adverse events including sepsis or invasive systemic infections. To date, Genentech has not received any reports of adverse events associated with use of Activase packaged with sterile water for injection.
Activase contains the active ingredient alteplase, which is supplied directly to hospitals and used in hospital settings. Activase is used to treat patients with acute ischemic stroke, which is caused by a blood clot in the brain’s blood vessels. It is also used to treat acute myocardial infraction, or heart attack, and to break apart acute massive pulmonary embolism, a very 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 is packaged with diluent for reconstitution and one transfer device. Affected products were distributed to hospitals nationwide.
Affected products include Activase in 100 mg vials with the UPC 502420008527 with lot numbers 3128243 with the expiration date of 9/30/2018; 31411239 with the expiration date of 9/20/2018; and 3166728 with the expiration date of 2/28/2019. The products were distributed from Jan. 6, 2017, to May 19, 2017.
Genentech is contacting distributors and customers to arrange for the return of all affected Activase products. Any adverse events related to the recalled Activase should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice