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Posts Tagged ‘childrens tylenol’

Tylenol, Motrin, Zyrtec and Benadryl.  What parent doesn’t have at least one of these pain relievers in the house if they’ve got kids?  It’s time for more Spring cleaning, and that includes the medicine cabinet.  

More than 40 over-the-counter infant’s and children’s liquid medications are being recalled by McNeil Consumer Healthcare, based in Fort Washington, PA.  The recall involves 43 various children’s versions of  Tylenol, Motrin,  Zyrtec and Benadryl.

The list of recalled products is found on the McNeil website,  http://www.mcneilproductrecall.com/page.jhtml?id=/include/mpr_ndc_finder.inc  where they say: 

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events.

However, as a precautionary measure, parents and caregivers should not administer these products to their children.

They don’t meet quality standards? 

Tylenol, Motrin,  Zyrtec and Benadryl products met Johnson & Johnson’s McNeil Consumer Heathcare division quality standards just fine until the Food and Drug Administration showed up.  Had the FDA not done a routine  inspection in April, no one would be the wiser that there was a problem in the first place.  Was it a surprise visit?

The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. “We are following through with the facility to make certain that everything has been checked,” said FDA spokeswoman Elaine Gansz Bobo.

According to McNeil and the FDA, some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.  Read more: http://www.nydailynews.com/lifestyle/health/2010/05/01/2010-05-01_fda_investigating_recall_of_childrens_medicine_including_tylenol_motrin_zyrtec_b.html#ixzz0msMXhTqH

Higher Concentrations? 

Particles?   What kind of particle exactly?  Particles of feces perhaps?  I call bullshit on Johnson and Johnson, McNeil, and maybe the FDA too.  Where were there own internal quality assurance people to ensure products standards? We are not talking about one product in dispute, but 43 different products that have different problems. 

The WSJ wrote that consumer complaints about certain over-the-counter children’s medications spurred the investigation that led to the recall.

It’s the latest in a spate of recall woes for J&J; in November it pulled some kinds of Tylenol Arthritis due to their moldy odor, then added more lots and products to the recall over the next few months.   As the WSJ notes, this latest recall signifies “another dent in J&J’s reputation as a model of corporate responsiveness.” The company’s handling of Tylenol poisonings in 1982 made it the subject of case studies in effective crisis management, but the recent recalls are fraying that reputation. http://blogs.wsj.com/health/2010/05/03/recall-roundup-jj-pulling-childrens-tylenol-motrin-other-meds/

There are plenty of third world countries with pharmaceutical production standards that fall far short of our standards.  Johnson and Johnson, the world leader in pharmaceuticals, medical goods and consumer products is an American company. The manufacturing plant in question is on American soil, with presumably American citizens working there.  Shame, shame for not enforcing standards, especially for children’s products and shame on the FDA as well.  Why did it take two weeks to notify the public that more than 40 children’s drugs were contaminated with yet to be named, “particles.”

Marc Boston, a McNeil spokesman, would not discuss the deficiencies cited by the FDA or say when the manufacturing facility was shut down. The company also declined to disclose the amount of products affected by the recall.  http://www.washingtonpost.com/wp-dyn/content/article/2010/05/01/AR2010050103051.html  Since when did FDA reports become sealed? It may be an ongoing investigation but I bet no one discloses anything more except when they announce that Tylenol is back in production,

The FDA regulates approximately 25 cents of every dollar spent annually by American consumers. The FDA is responsible for regulating products to ensure the safety of foods, drugs, biological products, medical devices, cosmetics, radiation-emitting devices, and more.  FDA’s Special Agents frequently investigate criminal wrongdoing by large companies. If these investigations lead to prosecution, the guilty officers and employees often receive federal prison sentences, while the company can expect to receive multimillion-dollar fines and restitution payments.  http://www.fda.gov/default.htm

Is the FDA’s Office of Criminal Investigations (OCI) looking into criminal activity?  What department of government investigates malfeasance of the FDA when it doesn’t do its job? For at least two weeks, these over the counter medicines were being used and sold, and shipped.  Did McNeil willfully ship known adulterated goods in interstate commerce? Did the FDA allow them xtra time to get there act together before notifying the public? 

To produce 43 different drugs at one facility, even if they operated at full steam means that there was a problem for a very long time.  When was the last FDA inspection?

“A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. http://en.wikipedia.org/wiki/Food_and_Drug_Administration ”  Four years after the study, we are in the same state of affairs. 

WAPO goes on to write,

This is at least the third major recall of Tylenol products by McNeil since 2008.

In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children after consumers complained of a mold-like odor and of temporary and minor nausea, stomach pain, vomiting and diarrhea. The company determined that some of the medicines had been contaminated by trace amounts of a chemical that is sometimes present on shipping and storage material.

In 2008, McNeil recalled 21 types of children’s and infants’ Tylenol liquid products, saying that although the products met internal standards, an unused portion of one inactive ingredient did not meet all quality standards.

“The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.” http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.  According to Wiki, along with their Fort Washington plant, McNeil also has plants in Lancaster, PA and Las Piedras, Puerto Rico. 

Here’s a hard pill to swallow, Johnson and Johnson is trading up one dollar midday, on the NYSE to $65.34. http://www.nyse.com/about/listed/jnj.html

  CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS’ TYLENOL® AND CHILDREN’S TYLENOL® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS’ MOTRIN® AND CHILDREN’S MOTRIN® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN’S ZYRTEC® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN’S BENADRYL® PRODUCTS

CLICK HERE FOR INFORMATION ON ALL RECALLED PRODUCTS FROM APRIL 30, 2010

UPDATED MAY 15. 2010. “This inspection report is pretty close to being the worst I’ve seen. It suggests that basically the FDA found an issue with almost every system at the plant.” 

In addition, the FDA said some drums used to transport raw materials to the Fort Washington facility were contaminated with a bacteria identified as B. cepacia.  http://money.cnn.com/2010/05/14/news/companies/tylenol_recall_plant_conditions/

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H1N1 FATALITIES via Rhizalabs

Fatal cases of Hemorrhagic Pneumonia related to the H1N1 Swine Flu are spreading throughout the world.  A huge number of H1N1 deaths have been counted in the last week.  Martial Law has already been declared in the Ukraine.  What country or state is next?

 20 NOVEMBER 2009 | GENEVA

Public health significance of virus mutation detected in Norway- Pandemic (H1N1) 2009 briefing note 17 —
— The Norwegian Institute of Public Health has informed WHO of a mutation detected in three H1N1 viruses. The viruses were isolated from the first two fatal cases of pandemic influenza in the country and one patient with severe illness….Worldwide, laboratory monitoring of influenza viruses has detected a similar mutation in viruses from several other countries, with the earliest detection occurring in April. In addition to Norway, the mutation has been observed in Brazil, China, Japan, Mexico, Ukraine, and the US….The mutations appear to occur sporadically and spontaneously. To date, no links between the small number of patients infected with the mutated virus have been found and the mutation does not appear to spreadhttp://www.who.int/csr/disease/swineflu/notes/briefing_20091120/en/index.html

Say what?  If the mutated virus is not spreading how is it being traced to numerous countries?  If the earliest detection was occurring in April, why were there no alarm bells going off? Or maybe they were, and you just couldn’t hear them.

Today, November 27, 2009 report from WHO says, “In the United States and Canada, influenza transmission remains very active and geographically widespread. In the United States, disease activity appears to have peaked in all areas of the country. In Canada, influenza activity remains similar but number of hospitalisations and deaths is increasinghttp://www.who.int/csr/don/2009_11_27a/en/index.html

Total over 622482 at least 7826

Back up to April of 2009, http://www.cbsnews.com/blogs/2009/04/28/politics/politicalhotsheet/entry4975598.shtml reported that is was The Department of Justice that has the established legal federal authority pertaining to the implementation of a quarantine and enforcement of quarantines of U.S. Citizens. Under approval from Health and Human Services, the authority to issue quarantines goes to the U.S. Surgeon General. http://www.surgeongeneral.gov/

As far back as November of 2005, the U.S. government was setting the stage for a pandemic such as this.   The Bush administration released the National Strategy for Pandemic Influenza providing an outline for coordination among federal agencies, the stockpiling and distribution of vaccines and anti-viral drugs, and, if necessary, government-imposed quarantines and limitations on gatherings. A review of http://homelandsecurity.tamu.edu/framework/special-issues-hurricane-katrina-1/national-strategy-for-pandemic-influenza/ with the electronic version removed from the web by the Obama administration http://www.whitehouse.gov/homeland/nspi.pdf.   Excerpted from our post at https://ahrcanum.wordpress.com/2009/09/28/h1n1-swine-flu-quarantine-usa/

It is not only the Feds, but back in April states began preparation for Quarantine Orders:

Florida Detentionhttp://www2a.cdc.gov/phlp/docs/FL%20Quarantine%20To%20Detention%20Facility%20Order%20Apr%2009%20252.pdf,  

Florida Quarantine to Residence http://www2a.cdc.gov/phlp/docs/FL%20Quarantine%20To%20Residence%20Order%20Apr%2009%20252.pdf  

Florida Quarantine to Residence for the Non Compliant http://www2a.cdc.gov/phlp/docs/FL%20Quarantine%20To%20Residence%20Order%20-%20NonCompliance%20Apr%2009%20252.pdf

Massachusetts, North Carolina, Washington also  have documents at the ready and can be viewed on the government site http://www2a.cdc.gov/phlp/H1N1flu.asp#IQ 

The state of Iowa’s has been removed by the CDC but can be viewed in its entirety at https://ahrcanum.wordpress.com/2009/09/04/swine-flu-quarantine-detention-order/ and also via http://www.zerohedge.com/sites/default/files/Iowa_Q_To_Residence.pdf .  The Iowa Antiviral Shortage Order can be seen at http://www2a.cdc.gov/phlp/docs/antiviral%20shortage%20order-2.pdf 

Iowa with state control over antivirals and quarantine measures in place, is also apparently America’s top destination for Hemorrhagic Pneumonia in the U.S.

Doctors in Iowa are observing hemorrhagic lungs in flu patients, but although the state has officially recorded 21 H1N1 deaths, actual cases may be higher as patient rights, laws prohibit the disclosure of specific numbers. The county’s medical examiner said he has performed autopsies on some residents who were never diagnosed with H1N1, but actually had it. “In the autopsy, what we’re seeing is very heavy, wet hemorrhagic lungs, lungs with a lot of blood in them,” said Dr. Gregory Schmunk via http://preventdisease.com/news/09/112209_hemorrhagic_pneumonia_in_iowa.shtml

 The Quarantine Social Distancing Law Project Sponsored by the U.S. Centers for Disease Control and Prevention (CDC) and directed by the Association of State and Territorial Health Officials (ASTHO), the Social Distancing Law Project was conducted in 17 jurisdictions in 2007 to assess the sufficiency of their legal preparedness to implement social distancing effectively. In addition, the participating jurisdictions assessed their legal authority to prescribe and dispense pharmaceutical drugs on a mass basis as a key potential countermeasure for an influenza pandemic http://www2a.cdc.gov/phlp/sdlp/ 

Vicks Recall

As we have been told H1N1, like the B Cepacia bacteria  generally poses little medical risk but the B Cepacia bacteria can causes deadly pneumonia that is antibiotic resistant and people with this are contagious. What you need to know about  B Cepacia is here http://www.cdc.gov/ncidod/dhqp/id_BcepaciaFS.html.  More importantly it  has been found in Vick’s nasal spray.  “The company has discovered, after routine testing, the spray could contain the bacteria B. cepacia, which can cause serious infections in people with a weak immune system or with lung conditions.” http://www.telegraph.co.uk/health/healthnews/6608952/Vicks-recalls-nasal-spray.html   

Children's Tylenol Recall

Additionally Johnson & Johnson’s McNeil unit is voluntarily recalling 57 lots of infants’ and children’s liquid Tylenol products because of possible bacterial contamination with B Cepacia bacteria .http://seattletimes.nwsource.com/html/health/2009945674_recall26.html  Anyone give there kids Tylenol for the flu lately?  Better check the lot numbers.

Throw in the “sounding the alarm about the rise of tuberculosis (TB) superbugs. Although the incidence of TB has fallen in many regions, the new findings suggest serious and growing problems with TB could on the horizon. The reason? Antibiotic resistant TB superbugs are emerging that could see virtually untreatable strains of the disease become widespread.  http://dinapharm.com/store/article_info.php?articles_id=358

Last week, Recombinomics, Inc. Founder and President, Henry L. Niman on events in Ukraine, said, “The rapid rise in reported infections, hospitalizations, and deaths in the past few days raise concerns that the virus is transmitting very efficiently…the spike in fatalities and the frequency in hemorrhagic cases in Ukraine have raised concerns.”  His focus has been on a little something called D225G.

D225G is in the receptor binding domain and therefore at the surface of HA, and several different polymorphism were noted at that position (D225G, D225E and D225N) suggesting the changes were to escape from the immune response.  Moreover the change was appearing on multiple different genetic backgrounds. This is not surprising, since position 225 is in an antigenic site and D225N was linked to the establishment of S31N in the H3N2 population.  http://www.recombinomics.com/News/11270902/D225G_Evade.html 

Hemorrhagic pneumonia was also observed in the 1918 pandemic and was thought to be linked to cytokine storm. Consequently, those with robust immune systems (previously health young adults) disproportionately died, which has also been seen in the current outbreak (Mexico, US, and worldwide).  However, the cases in Ukraine appear to be clustered, raising concerns that the virus has changed.http://www.recombinomics.com/News/11040901/Ukraine_Hemor_Clusters.html

The world’s most populated country is China where they are on high alert for any mutation where H1N5, Bird Flu has been seen.  Zhong Nanshan, director of the Guangzhou Institute of Respiratory Diseases in China’s southern Guangdong province, said the presence of both viruses in China meant they could mix and become a monstrous hybrid — a bug packed with strong killing power that can transmit efficiently among people.  “China, as you know, is different from other countries. Inside China, H5N1 has been existing for some time, so if there is really a reassortment between H1N1 and H5N1, it will be a disaster,” Zhong said in an interview with Reuters Television via http://www.reuters.com/article/GCA-SwineFlu/idUSTRE5AO16220091125

On Sept. 5 China became the first country to declare that it had discovered a vaccine, and by late October it had produced nearly 53 million doses. via http://www.starbulletin.com/news/nyt/20091112_chinas_tough_measures_on_flu_appear_to_pay_off.html  China has also been the most aggressive  country enforcing quarantines and medical detentions to slow the transmission of H1N1.

Zero Hedge at http://www.zerohedge.com/article/cdc-h1n1-forced-quarantine-docs-leak wrote, “the fall H1N1 pandemic may be a convenient pretext by which dangerous levels of expanding social control can be established by elites which have proven themselves utterly corrupt and morally bankrupt.”

Meanwhile, “If vaccines strengthen the immune system (as vaccine makers imply), then why do people who take such vaccines end up at higher risk of future infections? The only rational explanation for this is that vaccines compromise immune function. And if that’s true, then why should anyone take them in the first place? asks http://dinapharm.com/store/article_info.php?articles_id=357  The answer is of course, shut up and just get your damned flu shot.

May we remind you- If this is a true pneumatic plague, no H1N1 vaccine is going to stave off infection.  Plague is a bacteria, H1N1 is a virus. via https://ahrcanum.wordpress.com/2009/11/20/ukraine-h1n1-swine-flu-mutation-or-plagu/

Is anyone seeing a pandemic pattern here?  Doomsday is marked by some as 2012.  Will the H1N1 mutations similarities to the 1918 plague take that long to wipe out a large percentage of the population? 

Like the R.E.M song lyrics,” It’s the end of the world as we know it and I feel fine.” http://www.metrolyrics.com/its-the-end-of-the-world-lyrics-rem.html 

How are you feeling about all this?
 

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