You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
Genentech has issued the following Dear Healthcare Professional letter for users of Fuzeon and certain other other injection products:
IMPORTANT DRUG WARNING
IMPORTANT SAFETY INFORMATION REGARDING ALCOHOL PREP PADS MANUFACTURED BY TRIAD CO-PACKAGED WITH GENENTECH PRODUCTS
(Fuzeon® (enfuvirtide); Boniva® Injection (ibandronate sodium); Pegasys® (pegylated interferon alfa-2a); TNKase® (tenecteplase); Nutropin AQ® (somatropin (rDNA origin)) Pen 10 Kit; Nutropin AQ® (somatropin (rDNA origin)) Pen 20 Kit)
Dear Healthcare Professional:
Recall of Triad Group Alcohol Prep Products Due to Potential Microbial Contamination
Genentech, Inc., a member of the Roche Group, has learned of a voluntary product recall in the United States involving all lots of alcohol prep pads, alcohol swabs and alcohol swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group alcohol prep pads are co-packaged with the following Genentech products: Fuzeon®; Boniva® Injection; Pegasys®; TNKase®; Nutropin AQ® Pen 10 Kit; and Nutropin AQ® Pen 20 Kit. The
Genentech medicines have not been affected in any way. In the interest of patient safety, Genentech wants to ensure that you and your pa¬tients are aware of this recall of only the alcohol prep products by the Triad Group.
This recall by the Triad Group has been initiated due to concerns about potential bacterial contamination of the alcohol prep products with Bacillus cereus. This recall involves alcohol prep products marked as sterile, as well as non-sterile products. As indicated on the FDA website in regard to this recall: “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 the packaged Genentech products and components (with the exception of the alcohol prep pads) have not been contaminated and may continue to be used in accordance with the package insert.
Genentech recommends that you immediately discontinue use of the alcohol prep pads packaged with these medicines. Inform your patients of this recall and request that they immediately discontinue using the co-packaged alcohol prep pads. The prep pads should be disposed of in the trash. When administering an injection of any of these Genentech products, healthcare providers and patients should use an alternative alcohol prep product that is not involved with this 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.
Additional information on this recall by the Triad Group can be found on the FDA’s website: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ ucm239319.htm.
If you or your patients have any further questions or require additional information, please contact the Genentech Resource Center at 1-877-GENENTECH.
You are encouraged to report side effects associated with the use of these products to Genentech and the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, which can be found at www.fda.gov/medwatch or call 1-800-FDA-1088.
For the Fuzeon indication, full prescribing information, and important safety information, please visit www.fuzeon.com.
For the Boniva indication, full prescribing information, and important safety information, please visit www.boniva.com.
For the Pegasys indication, full prescribing information, and important safety information including Boxed WARNING and Medication Guide, please visit www.pegasys.com.
For the TNKase indication, full prescribing information, and important safety information, please visit www.tnkase.com.
For the Nutropin AQ indication, full prescribing information, and important safety information, please visit www.nutropin.com.
Sincerely,
Hal Barron, MD Executive Vice President Head, Global Development Chief Medical Officer
Genentech, Inc.
_____________________________
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
Manage your FDA Subscriptions:
- Update your preferences or unsubscribe
- Questions about this service? support@xxxxxxxxxxxxxxx
- Other inquiries? webmail@xxxxxxxxxx
U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
