Re: VIDEO -What to use if you don't want them using alcohol preps?

[Guest guest]

From what I read there, there is only a concern if they put you on the RediPen. Very likely, any clinic or Dr. that you go to while on tx, will have removed those alcohol things from the RediPen.However, hopefully you will get the pre-filled no muss, no fuss syringes. That's what they were using on my clinical trial.Gloria

So should we all be asking the labs and so to not use alcohol pads on us when they draw our blood and put in ivs and such? What do you suggest they use and do they have an alternative available if you ask? Cinder

From: Christ <ludichrist2000@...>Subject: [ ] VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads"009 - VCHepC" <VCHepC >, "Hepatitis C" <Hepatitis C >, "WebWarriors grp" < >Date: Monday, February 28, 2011, 3:33 PM

VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

Triad Pads Packaged with Pegasys In The U.S.

Genentech, Inc., a member of the Roche Group distributed the Triad pads packaged with Pegasys; "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."

Merck

PEGINTRON single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A Multidose RediPen® and INTRON®= "Merck medicines distributed in the "United States" are not impacted by the Triad Group recall". U.S. Merck issued a warning on Jan. 23, 2011 - Merck (known as MSD outside the United States and Canada) has become aware of the market recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by the Triad Group in the United States. The Triad Group recall impacts the alcohol prep pads that are co-packaged and distributed with the Merck medicines PEGINTRON® (peginterferon alfa-2b) single dose RediPen® and

PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A (interferon alfa-2b) Multidose RediPen® and INTRON® A Solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad

Group recall.

Upon discussion and agreement with local Ministries of Health, Merck will begin packaging orders without alcohol prep pads until a suitable alternative has been identified. It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded. Reported allegedly after using a Triad pad packaged with (Pegasys) peginterferon alfa-2a

Medpage;@ MSNBC also reported that a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December. He too has filed suit against Triad, with Genentech also named as a defendant". FDA RecallAlcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:

Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Medical, Walgreens, CVS, Conzellin. .. See; Triad: Drug Recall Notice Group's customer service hotline at (262) 538-2900. Reported @ MSNBCMSNBC

has reported the sad story of the Kotharis family who believe alcohol swabs made by TRIAD Group, Inc., were to blame for the death of their two year old son. The child on Kothari, died from a rare infection blamed on the wipes; which were allegedly contaminated with a bacteria called bacillus cereus. The hospital Children’s Memorial released this statement "Children’s Memorial Hermann Hospital is deeply saddened by the death of any child in our care," it read. "Memorial Hermann was notified of the product recall in January, one month after this child died. At that time, the product was removed from our shelves. We are dedicated to providing the highest standard of quality care and patient safety at Children’s Memorial Hermann Hospital." Triad Alcohol Pad Recall Announced on Good Morning America

...

Reported By MSNBC

Problems with sterilization, contamination

Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care. Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity. In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,†the report said. In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said. The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.However, inspectors said Triad’s processes “may not be adequate to sterilize†the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels†previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents. Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution. In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.“No action was taken on the distributed cases,†inspectors wrote.Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….

Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, said. From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.Source; MSNBC http://Hepatitis Cnewdrugs.blogspot.com/2011/02/hepatitis-c-medicines-packaged-with.html

[Guest guest]

Nope...  the alcohol pads in question came with Interferon shots.  They were pre-packaged.  This actually happened a few weeks ago and is still getting news.If you are concerned, the hospital can use Betadine instead of alcohol but expect some push back because it's not widely available and it's very expensive.

On Mon, Feb 28, 2011 at 5:18 PM, Cinder <datagrey@...> wrote:

 

So should we all be asking the labs and so to not use alcohol pads on us when they draw our blood and put in ivs and such? What do you suggest they use and do they have an alternative available if you ask? Cinder

From: Christ <ludichrist2000@...>Subject: [ ] VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

" 009 - VCHepC " <VCHepC >, " Hepatitis C " <Hepatitis C >, " WebWarriors grp " < >

Date: Monday, February 28, 2011, 3:33 PM

 

VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

 

Triad Pads Packaged with Pegasys In The U.S.

Genentech, Inc., a member of the Roche Group distributed the Triad pads packaged with Pegasys; " 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. "

Merck

PEGINTRON single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A Multidose RediPen® and INTRON®= " Merck medicines distributed in the " United States " are not impacted by the Triad Group recall " . U.S. Merck issued a warning on Jan. 23, 2011 - Merck (known as MSD outside the United States and Canada) has become aware of the market recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by the Triad Group in the United States. The Triad Group recall impacts the alcohol prep pads that are co-packaged and distributed with the Merck medicines PEGINTRON® (peginterferon alfa-2b) single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A (interferon alfa-2b) Multidose RediPen® and INTRON® A Solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad

Group recall.

Upon discussion and agreement with local Ministries of Health, Merck will begin packaging orders without alcohol prep pads until a suitable alternative has been identified. It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded. Reported allegedly after using a Triad pad packaged with (Pegasys) peginterferon alfa-2a

Medpage;@ MSNBC also reported that a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December. He too has filed suit against Triad, with Genentech also named as a defendant " . FDA RecallAlcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either " Triad Group, " listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Medical, Walgreens, CVS, Conzellin. .. See; Triad: Drug Recall Notice

Group's customer service hotline at (262) 538-2900. Reported @ MSNBCMSNBC has reported the sad story of the Kotharis family who believe alcohol swabs made by TRIAD Group, Inc., were to blame for the death of their two year old son. The child on Kothari, died from a rare infection blamed on the wipes; which were allegedly contaminated with a bacteria called bacillus cereus. The hospital Children’s Memorial released this statement " Children’s Memorial Hermann Hospital is deeply saddened by the death of any child in our care, " it read. " Memorial Hermann was notified of the product recall in January, one month after this child died. At that time, the product was removed from our shelves. We are dedicated to providing the highest standard of quality care and patient safety at Children’s Memorial Hermann Hospital. " Triad Alcohol Pad Recall Announced on Good Morning America

...

Reported By MSNBC

Problems with sterilization, contamination

Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care. Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity. In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,” the report said. In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said. The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.However, inspectors said Triad’s processes “may not be adequate to sterilize” the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels” previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents. Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution. In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.

“No action was taken on the distributed cases,” inspectors wrote.Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….

Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, said. From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.

Source; MSNBC   http://Hepatitis Cnewdrugs.blogspot.com/2011/02/hepatitis-c-medicines-packaged-with.html    

--  

Teri Gottlieb

MOVE ON.  It's just a chapter in the past, but don't close the book.  Just turn the page.

[Guest guest]

Teri and When I was on the clinical, there was no alcohol pads in the box of interferon. The clinic itself gave me those pads.At any rate, knowing that there is a big deal about something that has been used since forever, just don't use the pads in the kits. Truthfully, to me the most important thing the pads did, was to wipe off any little droplet of medication. I think I often missed the spot I had wiped on me, plus I didn't remember all the time. The alcohol pads are not necessary anyway.Gloria

Nope... the alcohol pads in question came with Interferon shots. They were pre-packaged. This actually happened a few weeks ago and is still getting news.If you are concerned, the hospital can use Betadine instead of alcohol but expect some push back because it's not widely available and it's very expensive.

On Mon, Feb 28, 2011 at 5:18 PM, Cinder <datagrey@...> wrote:

So should we all be asking the labs and so to not use alcohol pads on us when they draw our blood and put in ivs and such? What do you suggest they use and do they have an alternative available if you ask? Cinder

From: Christ <ludichrist2000@...>Subject: [ ] VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

"009 - VCHepC" <VCHepC >, "Hepatitis C" <Hepatitis C >, "WebWarriors grp" < >

Date: Monday, February 28, 2011, 3:33 PM

VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

Triad Pads Packaged with Pegasys In The U.S.

Genentech, Inc., a member of the Roche Group distributed the Triad pads packaged with Pegasys; "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."

Merck

PEGINTRON single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A Multidose RediPen® and INTRON®= "Merck medicines distributed in the "United States" are not impacted by the Triad Group recall". U.S. Merck issued a warning on Jan. 23, 2011 - Merck (known as MSD outside the United States and Canada) has become aware of the market recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by the Triad Group in the United States. The Triad Group recall impacts the alcohol prep pads that are co-packaged and distributed with the Merck medicines PEGINTRON® (peginterferon alfa-2b) single dose RediPen® and

PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A (interferon alfa-2b) Multidose RediPen® and INTRON® A Solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad

Group recall.

Upon discussion and agreement with local Ministries of Health, Merck will begin packaging orders without alcohol prep pads until a suitable alternative has been identified. It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded. Reported allegedly after using a Triad pad packaged with (Pegasys) peginterferon alfa-2a

Medpage;@ MSNBC also reported that a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December. He too has filed suit against Triad, with Genentech also named as a defendant". FDA RecallAlcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:

Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Medical, Walgreens, CVS, Conzellin. .. See; Triad: Drug Recall Notice

Group's customer service hotline at (262) 538-2900. Reported @ MSNBCMSNBC

has reported the sad story of the Kotharis family who believe alcohol swabs made by TRIAD Group, Inc., were to blame for the death of their two year old son. The child on Kothari, died from a rare infection blamed on the wipes; which were allegedly contaminated with a bacteria called bacillus cereus. The hospital Children’s Memorial released this statement "Children’s Memorial Hermann Hospital is deeply saddened by the death of any child in our care," it read. "Memorial Hermann was notified of the product recall in January, one month after this child died. At that time, the product was removed from our shelves. We are dedicated to providing the highest standard of quality care and patient safety at Children’s Memorial Hermann Hospital." Triad Alcohol Pad Recall Announced on Good Morning America

...

Reported By MSNBC

Problems with sterilization, contamination

Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care. Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity. In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,†the report said. In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said. The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.However, inspectors said Triad’s processes “may not be adequate to sterilize†the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels†previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents. Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution. In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.

“No action was taken on the distributed cases,†inspectors wrote.Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….

Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, said. From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.

Source; MSNBC http://Hepatitis Cnewdrugs.blogspot.com/2011/02/hepatitis-c-medicines-packaged-with.html

--

Teri Gottlieb

MOVE ON. It's just a chapter in the past, but don't close the book. Just turn the page.

[Guest guest]

Gloria,Alcohol pads may not be necessary but cleaning the area that you are going to give yourself a shot in IS necessary.  It is imperative that the area where you are giving yourself the shot is cleaned with alcohol before you inject.  You can use a cotton pad and rubbing alcohol from the bottle if you'd like but the area NEEDS to be sterile.  If it's not, you can get one serious staph infection from your shot.  You can DIE from a staph infection.  It's serious business.  And there is usually some sort of staph bacteria on your skin at all times.  You have to clean this off.  Trust me on this one guys.. this is where my lab background comes into play.  

Hugs,Teri

On Tue, Mar 1, 2011 at 8:51 PM, Gloria <gadamscan@...> wrote:

 

Teri and When I was on the clinical, there was no alcohol pads in the box of interferon.  The clinic itself gave me those pads.

At any rate, knowing that there is a big deal about something that has been used since forever, just don't use the pads in the kits.  Truthfully, to me the most important thing the pads did, was to wipe off any little droplet of medication.  I think I often missed the spot I had wiped on me, plus I didn't remember all the time.  The alcohol pads are not necessary anyway.

Gloria

 

Nope...  the alcohol pads in question came with Interferon shots.  They were pre-packaged.  This actually happened a few weeks ago and is still getting news.If you are concerned, the hospital can use Betadine instead of alcohol but expect some push back because it's not widely available and it's very expensive.

On Mon, Feb 28, 2011 at 5:18 PM, Cinder <datagrey@...> wrote:

 

So should we all be asking the labs and so to not use alcohol pads on us when they draw our blood and put in ivs and such? What do you suggest they use and do they have an alternative available if you ask? Cinder

From: Christ <ludichrist2000@...>

Subject: [ ] VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

" 009 - VCHepC " <VCHepC >, " Hepatitis C " <Hepatitis C >, " WebWarriors grp " < >

Date: Monday, February 28, 2011, 3:33 PM

 

VIDEO - Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

 

Triad Pads Packaged with Pegasys In The U.S.

Genentech, Inc., a member of the Roche Group distributed the Triad pads packaged with Pegasys; " 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. "

Merck

PEGINTRON single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A Multidose RediPen® and INTRON®= " Merck medicines distributed in the " United States " are not impacted by the Triad Group recall " . U.S. Merck issued a warning on Jan. 23, 2011 - Merck (known as MSD outside the United States and Canada) has become aware of the market recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by the Triad Group in the United States. The Triad Group recall impacts the alcohol prep pads that are co-packaged and distributed with the Merck medicines PEGINTRON® (peginterferon alfa-2b) single dose RediPen® and

PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A (interferon alfa-2b) Multidose RediPen® and INTRON® A Solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad

Group recall.

Upon discussion and agreement with local Ministries of Health, Merck will begin packaging orders without alcohol prep pads until a suitable alternative has been identified. It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded. Reported allegedly after using a Triad pad packaged with (Pegasys) peginterferon alfa-2a

Medpage;@ MSNBC also reported that a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December. He too has filed suit against Triad, with Genentech also named as a defendant " . FDA RecallAlcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either " Triad Group, " listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:

Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Medical, Walgreens, CVS, Conzellin. .. See; Triad: Drug Recall Notice

Group's customer service hotline at (262) 538-2900. Reported @ MSNBC

MSNBC

has reported the sad story of the Kotharis family who believe alcohol swabs made by TRIAD Group, Inc., were to blame for the death of their two year old son. The child on Kothari, died from a rare infection blamed on the wipes; which were allegedly contaminated with a bacteria called bacillus cereus. The hospital Children’s Memorial released this statement " Children’s Memorial Hermann Hospital is deeply saddened by the death of any child in our care, " it read. " Memorial Hermann was notified of the product recall in January, one month after this child died. At that time, the product was removed from our shelves. We are dedicated to providing the highest standard of quality care and patient safety at Children’s Memorial Hermann Hospital. " Triad Alcohol Pad Recall Announced on Good Morning America

...

Reported By MSNBC

Problems with sterilization, contamination

Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care. Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity. In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,” the report said. In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said. The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.However, inspectors said Triad’s processes “may not be adequate to sterilize” the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels” previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents. Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution. In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.

“No action was taken on the distributed cases,” inspectors wrote.Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….

Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, said. From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.

Source; MSNBC   http://Hepatitis Cnewdrugs.blogspot.com/2011/02/hepatitis-c-medicines-packaged-with.html    

--  

Teri Gottlieb

MOVE ON.  It's just a chapter in the past, but don't close the book.  Just turn the page.

--  

Teri Gottlieb

MOVE ON.  It's just a chapter in the past, but don't close the book.  Just turn the page.

[Guest guest]

Teri and AllOf course, I did not know this little fact!! We learn something new everyday don't we?Anyway, I like your suggestion of the cotton pad and rubbing alcohol. That sounds like the smartest way to go since this scare.Gloria

Gloria,Alcohol pads may not be necessary but cleaning the area that you are going to give yourself a shot in IS necessary. It is imperative that the area where you are giving yourself the shot is cleaned with alcohol before you inject. You can use a cotton pad and rubbing alcohol from the bottle if you'd like but the area NEEDS to be sterile. If it's not, you can get one serious staph infection from your shot. You can DIE from a staph infection. It's serious business. And there is usually some sort of staph bacteria on your skin at all times. You have to clean this off. Trust me on this one guys.. this is where my lab background comes into play.

Hugs,Teri

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[Guest guest]

This is one of those cases where what you don't know can kill you.  Did you know that a good number of the deaths that occur in hospitals after surgery are from staph infections?  That little buggar is one nasty bacteria and it's EVERYWHERE.  The other thing that is important when cleaning an area for an injection is to start at the center and make circles outward.  You don't ever want to bring the alcohol pad back and forth across the skin...  when you do that you are dragging the bacteria with you.  If someone goes to draw your blood and they do that swipe back and forth motion, make them do it again THE RIGHT WAY.  I promise you, you don't ever want a staph infection.  You wind up with a bump under your skin that looks like a banana.  It's that size and it hurts and it's hard as a rock and its full of pus.  It takes heavy antibiotics to kill it too.  That's some mean stuff there.

Hugs,TeriOn Wed, Mar 2, 2011 at 12:12 AM, Gloria <gadamscan@...> wrote:

 

Teri and AllOf course, I did not know this little fact!!  We learn something new everyday don't we?

Anyway, I like your suggestion of the cotton pad and rubbing alcohol.  That sounds like the smartest way to go since this scare.Gloria

 

Gloria,Alcohol pads may not be necessary but cleaning the area that you are going to give yourself a shot in IS necessary.  It is imperative that the area where you are giving yourself the shot is cleaned with alcohol before you inject.  You can use a cotton pad and rubbing alcohol from the bottle if you'd like but the area NEEDS to be sterile.  If it's not, you can get one serious staph infection from your shot.  You can DIE from a staph infection.  It's serious business.  And there is usually some sort of staph bacteria on your skin at all times.  You have to clean this off.  Trust me on this one guys.. this is where my lab background comes into play.  

Hugs,Teri

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Teri Gottlieb

MOVE ON.  It's just a chapter in the past, but don't close the book.  Just turn the page.