September 11, 2017

FDA: Genetech recalls three lots of Activase

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection.

The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be cracked or chipped at the neck of the vial and leaking.

To date, Genetech has received no reports of adverse events associated with use of the sterile water vials.

Posted 09/07/2017] AUDIENCE: Pharmacy, Critical Care Medicine ISSUE: Genentech 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 100 mg, may be cracked or chipped at the neck of the vial and leaking.

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