Wednesday, Sep 6, 2017
South San Francisco, CA -- September 6, 2017 --
December 2017 Update
On December 1, 2017 this recall was classified by the FDA as a Class 1 recall due to non-sterility of the Sterile Water for Injection vials. Genentech is conducting this voluntary recall due to the potential presence of cracked or chipped glass at the neck of Sterile Water for Injection vials that were packaged with Activase-100 mg. To date, Genentech has not received reports of adverse events associated with use of impacted Sterile Water for Injection. We take this very seriously and have taken steps to ensure removal of non-sterile vials from distributors and customers. Our number one focus is patient safety and we are pleased to work with the FDA to to conduct this voluntary recall.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), 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.
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.
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 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: NDC 50242-085-27. The product was distributed nationwide to hospitals.
The affected lots are:
Genentech Distribution Dates
Activase® (alteplase) vial - 100 mg
01/06/2017 – 05/19/2017
Genentech is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have lots of Activase that have been recalled should stop using the product and should return the affected lots to Genentech.
Consumers with questions regarding this recall can contact Genentech:
Medical Inquiries: Please contact Genentech Medical Communications (5am-5pm PT) at 1-800-821-8590 or the Patient Resource Center (6am-5pm PT) at 1-877-436-3683.
Drug Safety/Adverse Events: In the event of any adverse health effects associated with this product recall, contact Genentech Drug Safety/Adverse Events (available 24 hours) at 1-888-835-2555.
Cost Recovery: Genentech will issue a credit to your account for product that you return as part of this recall.
Return Processing Questions: Please contact FedEx Supply Chain at 1-877-674-2081.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Activase® (alteplase) is indicated for treating patients with acute ischemic stroke (AIS), which is caused by a blood clot in the brain’s blood vessels. Patients can receive Activase only if they begin treatment within three hours after their stroke symptoms start and only after bleeding in the brain has been ruled out.
Activase is approved for treating an acute myocardial infarction (AMI), also known as a heart attack. In patients whose heart attack puts them at low risk for death or heart failure, the benefit that comes from the use of Activase may be outweighed by the risk of stroke that Activase presents.
Activase is indicated to break apart an acute massive pulmonary embolism (PE), which is a large blood clot lodged in the blood vessels of the lung. The pulmonary embolism must be severe enough to block blood flow to the lungs and cause an unsafe drop in blood pressure.
Activase® (alteplase) is indicated for the treatment of acute ischemic stroke (AIS). Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within three hours after symptom onset.
Activase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure.
Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.
Activase is indicated for the lysis of acute massive pulmonary embolism (PE), defined as:
Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage (ICH); subarachnoid hemorrhage; active internal bleeding; recent (within three months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.
Do not administer Activase to treat acute myocardial infarction or pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within three months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.
Warnings and Precautions
Activase can cause significant, sometimes fatal, internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Heparin, aspirin, or Activase may cause bleeding complications; therefore carefully monitor for bleeding. If serious bleeding occurs, terminate the Activase infusion.
Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy.
Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents.
Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism
Consider the possible risk of reembolization due to the lysis of underlying deep venous thrombi patients with acute massive PE.
Coagulation Tests May be Unreliable during Activase Therapy
Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy.
The most frequent adverse reaction associated with Activase therapy is bleeding.
Allergic-type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.
Please see full Prescribing Information for additional Important Safety Information at https://www.gene.com/download/pdf/activase_prescribing.pdf
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.