FDA Hepatitis Update - Important information about alcohol prep pads packaged with Pegasys and certain other injection products

[Guest guest]

Please do not reply to this message.

Genentech has issued the following Dear Healthcare Professional letter for users

of Pegasys 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/SafetyAlertsforHumanMedical\

Products/ 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.

_____________________________

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration

Manage your FDA Subscriptions:

Update your preferences or unsubscribe

Questions about this service? support@...

Other inquiries? webmail@...

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

Please do not reply to this message.

Genentech has issued the following Dear Healthcare Professional letter for users

of Pegasys 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/SafetyAlertsforHumanMedical\

Products/ 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.

_____________________________

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration

Manage your FDA Subscriptions:

Update your preferences or unsubscribe

Questions about this service? support@...

Other inquiries? webmail@...

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420