Cathflo activase recall

Recalls that have been issued. Cathflo Activase (alteplase). Genentech, Inc. Drug Alert

The purpose of this letter is to inform you about the potential risk of impact on the sterility of Cathflo Activase (alteplase) and the voluntary recall of two batches of Cathflo Activase (alteplase) (batches ).

Note: This document provides detailed information about Cathflo Activase Side Effects associated with alteplase. Some dosage forms listed on this page may not apply specifically to the brand name Cathflo Activase. Applies to alteplase: intravenous powder for solution. Serious side effects of Cathflo Activase

Alteplase Injection (Cathflo Activase),, Liraglutide Injection,, . Lisdexamfetamine Dimesylate

Three cases of sepsis occurred 2 to 44 hours after treatment with Cathflo Activase. All of these patients had evidence of infection prior to administration of Cathflo Activase. An additional patient developed fever and lethargy within one day of Cathflo Activase administration, which required outpatient intravenous antibiotics.

Status, Ongoing. Mandated? Voluntary: Firm initiated. Recall Number, D- . Event ID, . Brand, CATHFLO ACTIVASE.

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. What is the Reason for Recall? Information describing how the product is defective.

Cathflo Activase is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. The dose of Cathflo Activase for patients weighing 30kg or more is 2 mg in 2mL. The dose of Cathflo Activase for patients weighing less than 30 kg is 110% of the internal lumen volume of the catheter, not to exceed 2mg in 2 mL.

Genentech issued a voluntary recall on two batches of Cathflo Activase (alteplase) due to the potential risk of impact on the sterility of the product.