Genentech on Wednesday recalled its clot-busting drug Activase due to sterility issues.
Here are five things to know.
1. Activase is used to treat acute ischemic strokes, which are caused by a blood clot in the brain, and heart attacks.
2. The recall applies to three lots of Activase that were co-packaged with vials of sterile water and distributed directly to hospitals nationwide. Activase comes in a powder form and is intended to be mixed with the sterile water prior to injection.
3. Genentech issued the recall after discovering the vials of sterile water, which Hospira manufactured, may be cracked and leaking.
4. Patients treated with the affected product could experience fever, chills, phlebitis and even sepsis, although Genentech has not received any reports of adverse events associated with the drug.
5. Genentech is informing distributors and customers about the recall and arranging for the return of all affected products.