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Safety

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Genentech Informs Customers Of Important Information
About Triad Group's Alcohol Prep Pads

 

Contact:
Media:
Tara Iannuccillo
(650) 467-6800

Investor:
Investor Relations North America
(650) 225-4150

 

FOR IMMEDIATE RELEASE - January 13, 2011 -Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, (http://www.fda.gov/Safety/Recalls/ucm239219.htm). The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines, Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase to customers in the United States.

According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

It is important to note, that Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol for disinfecting the injection site prior to administration. Genentech is in discussion with the FDA and is currently assessing alternatives to address the situation. The company plans to issue a Dear Healthcare Provider letter to potential prescribers and pharmacists to make them aware of the Triad product recall and the need to discontinue use of the alcohol prep pads packaged with Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase.

Further information about the Triad Group recall can be found on the FDA website at
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.

Patients should consult their healthcare provider for further information. Healthcare providers with questions may contact the Patient Resource Center at 1-877-436-3683 between the hours of 6 am and 5 pm Pacific Time.

For the Boniva indication, full prescribing information, and important safety information, please visit http://www.boniva.com.

For the Fuzeon indication, full prescribing information, and important safety information, please visit http://www.fuzeon.com.

For the Nutropin A.Q. Pen indication, full prescribing information, and important safety information, please visit http://www.nutropin.com.

For the Pegasys indication, full prescribing information, and important safety information including Boxed WARNING and Medication Guide, please visit http://www.pegasys.com.

For the TNKase indication, full prescribing information, and important safety information, please visit http://www.tnkase.com.

About Genentech
Founded more than 30 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.

 

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