Roche Recalls Three Lots of Activase on Sterility Issues

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Roche’s subsidiary, Genentech, issued the voluntary recall of the anti-stroke drug because of compromised vials containing sterile water that were packaged with the drug.

Roche’s Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, which were co-packaged with sterile water for injection, to the hospital level because of sterility issues, according to a Sep. 6, 2017 press release by FDA. The vials of sterile water for injection that were packaged with Activase 100 mg may be cracked or chipped at the neck of the vial and leaking. These vials were manufactured by Hospira, a Pfizer company which the drugmaker acquired for $17 billion in 2015.

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 the use of impacted sterile water for injection.

Activase is supplied directly to hospitals and used in a hospital setting. The drug is indicated for treating acute ischemic stroke, caused by a blood clot in the brain’s blood vessels; acute myocardial infarction; and acute massive pulmonary embolism. It 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. The product was distributed nationwide to hospitals.


Source: FDA