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Genentech announced a voluntary recall of three lots of Activase (alteplase) 100mg vials co-packaged with Sterile Water for Injection due to a possible crack or chip at the neck of the vial causing a leak.
Activase is available as lyophilized powder in 100mg vials without vacuum. Each Activase vial (58 million IU) is co-packaged with a diluent for reconstitution and a transfer device. The affected product contains Lot #3128243, #3141239, and #3166728 with NDC 50242-0085-27. These lots were distributed to hospitals between January 6, 2017 and May 19, 2017.
Using compromised Sterile Water for Injection may cause fever, chills, phlebitis, and granuloma. Serious adverse events such as sepsis or invasive systemic infections may also result.
Activase, a tissue plasminogen activator (tPA), is indicated for the treatment of acute myocardial infarction (AMI), to reduce mortality and incidence of heart failure. It is also indicated for the treatment of acute ischemic stroke and acute massive pulmonary embolism (PE) for lysis.
Genentech is informing its customers and distributors and is arranging for return of all impacted products. Healthcare providers in possession of the recalled lots should discontinue use and return them to the Company. There have been no reports of adverse events associated with the impacted Sterile Water for Injection to date.
For more information call (800) 821-8590 or visit FDA.gov.
