Medicine recalls
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| The United States: Genentech issues voluntary nationwide recall of three lots of Activase (Alteplase) - 100mg due to lack of sterility assurance of the sterile water for injection |
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The US Food and Drug Administration (FDA) announces that Genentech, a member of the Roche Group, 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 100mg, may be cracked or chipped at the neck of the vial and leaking. The affected lots (expiration date) are 3128243 (9/30/2018), 3141239 (9/30/2018) and 3166728 (2/28/2019).
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 100mg vials without vacuum. Each 100mg Activase vial (58 million IU) is packaged with diluent for reconstitution (100mL Sterile Water for Injection, USP), and one transfer device (NDC 50242-085-27).
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm574980.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Sep 8, 2017
Issued at HKT 16:00
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