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Genentech Recalls Three Lots Of Activase (alteplase) 100mg Vials


Roche Group (RHHBY) company Genentech is 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 (PFE) company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

Genentech has not received reports of adverse events associated with use of impacted Sterile Water for Injection. The use of recalled 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.

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.

The affected lots are Activase (alteplase) vial - 100 mg, UPC 50242008527, with NDC 50242-0085-27, Lot # 3128243 with 9/30/2018 expiration date, Lot # 3141239 with 9/30/2018 expiry, Lot # 3166728 with 2/28/2019 expiry, with 01/06/2017 - 05/19/2017 distribution dates.

by RTTNews Staff Writer

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