Fires Reporting as Human-caused | Update 3

Updated 7PM PST / 10PM CST

Officials Confirm Worst Fears

Gatlinburg Fire in the Great Smoky Mountains National Park (Credit: GSMNP)

Gatlinburg Fire in the Great Smoky Mountains National Park (Credit: GSMNP)

Fire Officials have confirmed the worst fears of this wildfire starting from the Chimney Tops 2 Fire located within the Great Smoky Mountains National Park that was reported at 5:20 PM CST on November 23rd.  The wildfire started in a remote area (Chimney Tops) where it would quickly spread due to severe drought and becoming a wind-driven event along with short-range spotting.

Currently, the wildfire has moved down the mountain into a mountainous town, Gatlinburg, Tennessee where it has consumed 15,653 acres of brush, hardwood slash and leaf litter.  The fire has also stolen much more just acres of lands but killed at least seven (7) people and destroyed 700 structures.  These are businesses and homes that have been taken by so many who are hurt, angry and dumbfounded how someone could actually start a fire on purpose.

There have also been reports of people missing from the Gatlinburg and Sevierville areas.  We will broadcast all missing person information with permission by the Family and/or Law Enforcement Officials.

The fire is now 10% contained.

Strike Team (Credit: Mt Juliet Fire)

Strike Team (Credit: Mt Juliet Fire)

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How YOU Can Help Evacuees

List of Organizations….Here is a compiled list put together by a local media outlet.  http://www.wbir.com/news/local/how-to-help-gatlinburg-pigeon-forge-fire-evacuees/357810685

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Missing Person:  Brad Phillips

Missing….We have information that has come to light about a missing man around the time the wildfires occurred.  He was reported as missing as of yesterday (11/28/2016) around 8:00 PM CST.  He spoke with family and them his own house was destroyed.  Brad Phillips’ daughter was asking for assistance on Twitter to help search Shelters as his family is out of the area.

We are doing a repost by the Amanda Phillips, the daughter of missing Brad Phillips from Gatlinburg/Sevierville, TN.  Please circulate his photo and let’s help this lady find her missing Dad.

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Looking Through The Eyes of Social Media

This is all about what the news, residents and those on the fire ground are saying about the wildfires, etc.

The Dollywood Foundation….states to pay $1,000/month for six (6) months to families who lost their homes. – Media

National Media Coverage….Twitter users took to Social Media again to say that the Gatlinburg wildfires and the loss of life/property affecting economic and disrupting lives is more important than covering political news.  Calls for CNN, Fox News, Associated Press and others to report nationally this disturbing wildfires.  Some networks felt this was not a big enough national newsworthy story. – Media

Gatlinburg is the Heart of Tourism….Thousands rely on its tourism industry to make a living; this fire is their worst nightmare. – Twitter user

Rain Falling….is helping wildfires but not firefighters due to the heavy smoke billowing in the area making firefighting efforts difficult and dangerous. – Twitter user

Scary….This is insane and scary as hell. – Twitter user

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Follow Us!

DYK?

We research our articles with some Posts taking hours to find correct and accurate information.  As some of you know from many Political posts, there is fake news out there with one of our Political winners tweeting about 170,000 acres have been destroyed.  Others stating the whole City of Gatlinburg has been destroyed, which is simply not the truth.

Follow Us and get your news feed fix from us and learn what information is the truth.  You can “Follow Us” here and, you can find us on Facebook and, Twitter (@nwfireblog).  We would love to have you onboard with us.

Thank you for reading our Blog.  We wish you nothing but Safety today. – Ed.

(c) The #NWFireBlog

Fires Reporting as Human-caused | Update 3

Updated 6:30 AM PST / 9:30 AM  CST

Reports of Human-Caused Ignited Sparks Many Emotions

A large mainstream media outlet was sounding the alarms saying Fire Officials are reporting the nearly 15,000 acres has been consumed, taking along with 250 structures and killing three (3) people.

Though human-caused can have several meanings, we did not want to come right out and say this is Arson related but a trend in Tennessee lately has shown that most of the wildfires in this State have been just that – Arson.  We are hoping the cause has a different outcome but we are waiting and hopeful.

Wind gusts were reported as high as 87 mph which has been one of the most biggest factors in this fires with more than 10 wildfires firefighters have to fight head on.  Resources are quickly being drained though hundreds if not thousands of fire crews are fighting dangerous flames at any given single time making conditions just even that more difficult and frustrating to Officials.

The Red Cross, one of the largest Incident Cooperators has reported providing 10,000 meals and snacks to those who are in Shelters and 1,000 meals to Firefighters.

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How YOU Can Help Evacuees

List of Organizations….Here is a compiled list put together by a local media outlet.  http://www.wbir.com/news/local/how-to-help-gatlinburg-pigeon-forge-fire-evacuees/357810685

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Please Help…..Find Missing Gatlinburg/Sevierville Man

Missing….We have information that has come to light about a missing man around the time the wildfires occurred.  He was reported as missing as of yesterday (11/28/2016) around 8:00 PM CST.  He spoke with family and them his own house was destroyed.  Brad Phillips’ daughter was asking for assistance on Twitter to help search Shelters as his family is out of the area.

We are doing a repost by the Amanda Phillips, the daughter of missing Brad Phillips from Gatlinburg/Sevierville, TN.  Please circulate his photo and let’s help this lady find her missing Dad.

DYK?

We research our articles with some Posts taking hours to find correct and accurate information.  As some of you know from many Political posts, there is fake news out there with one of our Political winners tweeting about 170,000 acres have been destroyed.  Others stating the whole City of Gatlinburg has been destroyed, which is simply not the truth.

Follow Us and get your news feed fix and learn what information is the truth.  You can “Follow Us” here and, you can find us on Facebook and, Twitter (@nwfireblog).  We would love to have you onboard with us.

Thank you for reading our Blog.  We wish you nothing but Safety today. – Ed.

(c) The #NWFireBlog

The Gatlinburg Fire are now Gatlinburg Fires | Update 2

Updated 11:30 PM PST / 2:30 AM  CST

How This Fire IS so Dangerous for its People

Gatlinburg, Tennessee has had several wildfires touching their town but this has been one of the worst in history and in the County (Sevier).  As we had reported on other wildfires in Tennessee most of them have been Arson caused.

Though we do not know the official cause of this wildfire(s) at this moment, what we know is that fires have been reported as several starts from various causes such as an outside wildfire and embers carried into the area or those reporting fire running down the Chimney Top fire into the town.  As some of you may know, Fire investigators will not be able to gain access to the burned out areas until it has been contained, extinguished and cooled off.

Please pray for those that work/play/live in Tennessee and First Responders who leave their own families and friends behind to respond to these wildfires.  We also ask that you think and pray for those who are supporting those on the fire ground, in the EOC, Red Cross, Incident Cooperators and so many  others we are unable to include in this post. (See some of the listed below)

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Incident Cooperators

Emergency Management….

  • Tennessee Emergency Management Agency (TEMA)

Fire/EMS/Law Enforcement…..

  • TN Dept. of Ag
  • TN Dept. of Forestry,
  • State Fire Marshal
  • Dept. of Corrections
  • MIlitary
  • TN Highway Patrol (THP)
  • TN National Guard
  • TN Fire Mutual Aid agencies
  • Chattanooga FD (Fire crew + BC)

Government Agencies…..

  • Commerce & Insurance
  • Environmental
  • Conservation
  • TN DOT
  • State Parks
  • TN Wildlife Reserve Agency
  • TN Dept. of Public Health and Human Services
  • Dept. of Tourist Development

Special Assignments

The following Agencies have been tasked with various responsibilities and duties, as part of this wildfire incident.

TN Dept. of Health…Consulting to send medical units from surrounding counties with assistance with medical transports.

TN Highway Patrol…..Deploying strike teams to assist with evacuations and traffic control.

National Guard…..Mobilizing 100  personnel from Eastern TN, providing transportation for 1st responders, removing light debris and assisting with welfare checks.

TN DOT…..Securing fuel resources & equipment, replenishing diesel fuel for Firefighter/1st responders’ vehicles.

TN Dept. of Tourist Development…..ID’ing lodging resources to assist those displaced persons.

TN Fire Mutual Aid Coordination…..Coordination of 50 – 60 fire apparatus from local Fire Departments.

TN State Governor…..Declared State of Emergency.  Went to visit with 1st Responders and see the destruction himself.

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Evacuations

Areas….The following have evacuated from Gatlinburg, Pigeon Forge and other parts in Sevier County.

Shelters (People)….1200 ppl have evacuated and are Sheltering in Place at the following locations:

  •  Gatlinburg Community Center
  • Rocky Top Sports Rink
  • Le Corte Center @ Pigeon Forge
  • Liberty Baptist Church (Wears Valley)
  • Iglesia Cristina La Duz Da Jesus (Sevierville)
  • First Red Bank Baptist Church (Sevierville)
  • First Baptist of Sevierville
  • River Plantation RV Resort
  • Anchor Down RV Resort
  • Trinity Baptist Church

Shelter (Pets)….The following are those that are offering or assisting with Animals & Livestock Shelters

  • Douglas Lakeview Stables. Kristi @ 864-671-8439.  1650 Providence Road, Sevierville. Call first. Offering pasture for animals & livestock.
  • The Barker Lounge. Lory.  865-771-3738, Offering shelter facilities for overnight lodging of pets.

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Damage Assessments

It has been reported by numerous sources that the following has occurred.

Structures Impacted…..100 homes in Sevier County.  10 homes including 30 structures including a 16-story hotel on Regan Drive, the Driftwood Apartments and others near the Park Vista Hotel (as of 2 AM CST) in Gatlinburg.

Injuries

Burned….3 severely burned residents, current conditions are unknown (3rd hand report).  1 Official report (male evacuee), current condition unknown

Fatalities….. 0.

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Closures

Highway 441… has been closed out of Gatlinburg, except for emergency only traffic.  The exit of  Highway 441 outside the City will remain open to allow those to still leave if they wish to.

Schools…..Green, McMinn and Sevier County schools have been closed.  NOTE :  Cocke County was delayed two hours.

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Resources & Alerts for Evacuees

 

Stay off Cell Phones…. Please stay off cell phones unless it is an emergency.  Officials wish to have these lines cleared to allow for emergency traffic only.

 

City Closed… No one is being allowed back into the City. Those who are still in the City, need to evacuate immediately! Also the National Park has been closed as well.

Red Cross App…. Let your friends and loved ones know you are safe and well and/or those looking for loved ones can also use this app.  Go to the American Red Cross app @ https://safeandwell.communityos.org/cms/index.php

Facebook App….Let your friends and loved ones know you are safe and well by checking into Facebook’s activated Safety Check app here –> https://www.facebook.com/about/safetycheck/

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Looking Through The Eyes of Social Media

Here is an updated look through those posting about the wildfire and what they are seeing through their own eyes.

Suspected Arson?…..As you may wonder, some are starting to speculate it could be arson related. (No confirmation on our part yet of the cause.)

Mainstream Media…..Users on Twitter took out their frustrations of networks such as CNN and other networks covering the Political world while a complete city in TN was burning down. (Ed. Note:  We are showing actually many mainstream media outlets covering this large scale wildfire but not as in depth as our Posts).

Ripley’s Aquarium…..Officials were reportedly saying that the Aquarium are still intact and the facility’s power generated was activated keeping all animals all safe.

Downtown Gatlinburg’s areas…..Reports that most of damage has been done but most of DT’s areas are still intact.

Amateur Radio communications on Stand-by…..The TN ARES community is on Stand-by and ready to help whenever needed but for now, the local communities in Sevier, Jefferson and Knox Counties are handling all communications for Command, TEMA and for Red Cross (Red Cross org + 2 shelters as Liasion with Command).

Here is a snapshot of one ARES member posting in the Community on Facebook.  Local HAMS are assisting in local communities.  12 wildfires are not burning but blazing in Eastern TN.  Fires threatening resort communications.  High wind with gusts up to 70+ mph.  Tinder dry conditions.

Fire started on Chimney Top fire in Great Smoky Mountains National Park.  550 acres.  0% contained. Embers carried to communications outside of Park starting new fires.  Down power lines starting more fires.

No fatalities have been reported but three have suffered burns.  Numerous businesses and homes have been destroyed.

Heroes In Action…..Earlier this morning, TN State Troopers walked around in Gatlinburg, TN as fire surrounded them to rescue multiple people trapped by flames.

Bear Rescued…..Footage of a small bear cub is seen running around a heavily smoky roadway where a man is being chased by the animal holding on for dear life, as he gravitates to the man’s leg.  So cute but so sad animals are being smoked out. KUDOS, to his rescuer!

Destruction….Over 100 structures said to be damaged/destroyed in Gatlinburg.  Heavy rain is happening now, however buildings are still burning.

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How YOU Can Help Evacuees

List of Organizations….Here is a compiled list put together by a local media outlet.  http://www.wbir.com/news/local/how-to-help-gatlinburg-pigeon-forge-fire-evacuees/357810685

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Please Help…..Find Missing Gatlinburg/Sevierville Man

Missing….We have information that has come to light about a missing man around the time the wildfires occurred.  He was reported as missing as of yesterday (11/28/2016).  He spoke with family which he stated that his own house was destroyed.

We are doing a repost by the Amanda Phillips, the daughter of missing Brad Phillips from Gatlinburg/Sevierville, TN.  Please circulate his photo and let’s help this lady find her missing Dad.

She states she needs assistance searching shelters as family is not in the area to assist and asking those on Social Media channels to help search shelters.

 

Thank you for reading our Post about these terrible fires in Tennessee.  Please join us in keeping all those in TN in our Thoughts and Prayers this evening. – Editor.

(c) The #NWFireBlog

National Preparedness Month | Day 4 | Pets Are People Too

RECAP

Now, that you have created your Evacuation plan putting it into practice and created your Out-of-State contact and assembling  your First Aid Kit, did you remember to include your Pets in your Evacuation Plan?  Well, we will discuss how pets are important and as you know, we treat them just like they are part of our Family [Pack].

PURPOSE

Pets are people too!  Okay, not technically but they are definitely part of the Family and must be included in your Plan.  On a recent wildfire, a firefighter was seen pictured with an evacuated resident’s dog.  By Planning to include your Pet and making sure to bring your loved one with you to your “meeting place” is sure to reduce stress and worry.  Now, we are not saying to do this at every cost, including your life – but do it as safely as best as you can when you are evacuating.

ALTERNATIVES

Some have left pets behind because they have had no choice but to do so.  In light of recent Washington State wildfires, there have been plenty of warnings of impending danger with fires coming towards them and alerts stating where pets and large animals could be safely boarded.  If you find that you may or may not be able to evacuate with your pet, create a Plan that will allow for another to rescue your pet or ask your nearest animal shelter or pet rescue organization how you can include your Pet[s] into your Evacuation Plan.  We promise this will keep worry off of your mind and knowing that he or she will be safe.

As previous K9 owners ourselves, it would be very painful  for us to have to leave them behind.  Remembering that last statement, we always had them in our Evacuation plan to go with us and ready at a moment’s notice.

In addition to including your Pet, it is very important to make sure that your pet is chipped as he or she could easily be separated from its collar and tags.  Most Vets can check the chip by scanning the device – returning their beloved pet[s] to them quickly.

BE PRO-ACTIVE, NOT REACTIVE

Including your pet[s] or large animals into your Evacuation plan will save time in knowing what to do, lessen stress and worry and keeping your family intact. However, sometimes evacuating with your pet at that moment in time may not be possible and therefore, you need to have a plan of what to do when leaving your pet behind.  No one really wants to even think of that possibility but in reality, you need to have your practiced plan in force.

This post is to help Get the Conversation Started and thinking about including your Pet in your Evacuation Plan, if not already thought about.  We will discuss later on what to bring for your Pet in the topic “Go Kits” for Your Pets.

Thanks for following us!  We appreciate you reading our post today.  Stay tuned for 26 more National Preparedness Daily Tips.

[c] 2015 The NW Fire Blog

DRUG RECALL: Gastroade Xtra by Cox Veterinary Labs due to Unapproved Drug by FDA

Contact:
Consumer:
Jeanne Buffington
jeanne@coxvetlab.com

Gastroade Xtra (Omeprazole)

FOR IMMEDIATE RELEASE — January 23, 2015 — Chester, SC — Cox Veterinary Laboratory, Inc. is voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as an OTC drug for use in horses, and contains Omeprazole. This recall has been initiated due to information from the FDA that Gastroade Xtra must have an approved new animal drug application to be legally marketed in the United States. Gastroade Xtra is not approved by the FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration. As a consequence, Cox Veterinary Laboratory has ceased all production and sales of Gastroade Xtra and is recalling the product..

Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not yet been established. To date, however, there have been no reported adverse events associated with the use of Gastroade Xtra.

Gastroade Xtra is labeled for the care of gastric ulcers in horses. Gastroade Xtra is a paste that is packaged in a 32 ml tube bearing the name Gastroade Xtra, Omeprazole 2.28g.

Aided with the information provided by the FDA, Cox Veterinary Laboratory is notifying its distributors and customers by a letter sent certified mail directly and through this press release of this voluntary recall. Cox Veterinary Laboratory will arrange for a return of all recalled product.

Consumers and distributors that have unused Gastroade Xtra should stop using this product immediately and contact Cox Veterinary Laboratory to arrange for the return of the product.

Horse owners, caretakers and veterinarians should report to the FDA any adverse events,
including ineffectiveness, in horses that received unapproved omeprazole products. Information on reporting adverse events for approved or unapproved animal drugs can be found at:  http://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm.

Complaints about approved and unapproved animal drug products can be reported by calling a consumer  complaint coordinator, within your FDA District Office or by filing a Veterinary Adverse Drug Reaction report.

Affected lots include Batch 0052 (UPC 091037382986) manufactured 5/29/2014.

Questions regarding this voluntary recall should be addressed to Jeanne Buffington by email at jeanne@coxvetlab.com from Monday to Friday, 10 am to 4pm, EST.

Consumers should contact their veterinary healthcare provider if they have experienced any problems that may be related to the use of this drug product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

REPOST via FDA.gov – http://www.fda.gov/Safety/Recalls/ucm431425.htm

 

FDA Safety Alerts – June 2, 2014

Safety Alerts for June 2, 2014

Soliris label 2

Alexion Initiates Voluntary Nationwide Recall of Certain Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion Due to the Presence of Visible Particulate Matter in a Single Lot

— Alexion’s global supply chain continues to provide Soliris to commercial and clinical patients without interruption —

Contact
Consumer:
1-888-765-4747

Media:
Irving Adler, 203-271-8210
Executive Director, Corporate Communications

Kim Diamond, 203-439-9600
Senior Director, Corporate Communications

FOR IMMEDIATE RELEASE – June 2, 2014 – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process. Alexion does not anticipate any interruption to patient supply. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S. No safety risks to patients who have received Soliris have been identified. There is no financial impact from the voluntary recall announced today..

The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. Following this voluntary recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.

The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As product from the affected lot was last shipped on Oct. 29, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.

Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product from the identified lots was last shipped on October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.

The following table lists the lots that are being recalled, which were distributed in the U.S. to wholesalers, hospitals, and pharmacies:

Product Lot Expiration Date First Ship Date Last Ship Date
Soliris®(eculizumab)

300 mg/30 mL

Concentrated solution for intravenous infusion only

NDC 25682-001-01

10007A July 2015 June 17, 2013 Oct. 29, 2013
10002-1 Aug 2014 Sept 6, 2012 Sept 9, 2013
00006-1 Aug 2014 Oct 12, 2012 May 15, 2013
10003A Nov 2014 Mar 28, 2013 Oct 3, 2013
10004A Feb 2015 Feb 4, 2013 Sept 24, 2013
10005A July 2015 May 15, 2013 Oct 28, 2013
10005AR July 2015 Sept 23, 2013 Sept 26, 2013
10006A July 2015 July 8, 2013 Oct 24, 2013
10008A Aug 2015 Aug 16, 2013 Oct 30, 2013

Soliris label 1

Alexion is notifying its distributors and customers by letter being sent via Federal Express and is arranging for replacement of all recalled products. Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747), Monday-Friday from 8:30am to 5:00pm Eastern Time (ET). Unaffected lot numbers can continue to be used according to the instructions for use.

Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747, Monday-Friday from 8:30am to 5:00pm ET. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Soliris® (eculizumab)

Soliris® (eculizumab) is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the U.S. (2007), European Union (2007), Japan (2010) and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is indicated to reduce hemolysis in PNH patients. Soliris is also approved in the U.S. (2011), the European Union (2011), Japan (2013) and other countries as the first and only treatment for patients with atypical hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare and life-threatening genetic disorder characterized by complement-mediated thrombotic microangiopathy, or TMA (blood clots in small vessels). The effectiveness of Soliris in aHUS is based on the effects on TMA and renal function. Soliris is not indicated for the treatment of patients with Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). More information, including the full prescribing information on Soliris, is available at www.soliris.net.

Important Safety Information

The U.S. product label for Soliris includes a boxed warning: “Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see Warnings and Precautions (5.1)]. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection [See Warnings and Precautions (5.1) for additional guidance on the management of the risk of meningococcal infection]. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.2)]. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747).”

In patients with PNH, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of patients with PNH should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Please see full prescribing information for Soliris, including boxed WARNING regarding risk of serious meningococcal infection.http://soliris.net/sites/default/files/assets/soliris_pi.pdf

About Alexion

Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH and aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates, including asfotase alfa, across multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexionpharma.com.

Safe Harbor Statement

This news release includes forward-looking statements relating to continued adequacy of supply of Soliris, and identification and correction of the cause of the visible particles. These statements are subject to risks, uncertainties and other factors, including risks related to continuous product inventory and supply, the uncertainties involved in manufacturing of biologic products, and whether the FDA, EMA or other international regulatory authorities decide to take corrective or disciplinary actions against Alexion, as well as the risks that are described in detail in Alexion’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to place undue reliance on these forward- looking statements. All forward-looking statements are based on information currently available to Alexion, and Alexion assumes no duty or obligation to update or revise any such forward-looking statements or any other statement in this report.

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Hill's Pet Science Diet label

Hill’s Pet Nutrition, Inc. Voluntarily Recalls 62 Bags of “Science
Diet® Adult Small & Toy Breed™” Dry Dog Food in California,
Hawaii and Nevada Because of Potential Health Risk

Contact
Consumer:
1-800-445-5777

FOR IMMEDIATE RELEASE – June 2, 2014 – Hill’s Pet Nutrition, Inc. of Topeka, KS is voluntarily recalling 62 bags of Science Diet® Adult Small & Toy Breed™ dry dog food as they have the potential to be contaminated with Salmonella. The suspect product, part of a single production run, was distributed to 17 veterinary clinic and pet store customers in California, Hawaii and Nevada between April 24 and May 13, 2014. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

This voluntary recall is limited to 62 15.5 lb. bags of Science Diet® Adult Small & Toy Breed™ dry dog food with the Stock-Keeping Unit (SKU) code, “Best before” date and production code shown below. This product was accidentally released, as revealed during a routine inventory reconciliation. All 17 affected customers have been contacted by Hill’s and there have been no reported illnesses related to this product to date.

Product Name Bag Size SKU “Best Before” Date/ Production Code
Science Diet® Adult Small & Toy Breed 15.5 lbs. 9097 08 2015 M094

The SKU number is located on the bottom of the bag, both side panels and on the back lower right hand corner below the UPC code. As illustrated below, the “Best before” date and production code is stamped on the top, middle of each bag.

Consumers who may have purchased any of these specific 62 15.5 lb bags of Science Diet® Adult Small & Toy Breed™ dry dog food should discontinue use of the product and immediately call Hill’s Pet Nutrition at 1-800-445-5777 Monday-Friday during the hours of 7am-7pm (CT). Hill’s will arrange to collect the unused portion of the product at its own expense at a time convenient for the consumer and will provide a full refund.

This voluntary recall does not impact any Science Diet® Adult Small and Toy Breed™ products with different “best before” dates or any other Science Diet products.

Hill’s Pet Nutrition is dedicated to providing high-quality, safe products and regrets the need for this voluntary recall. For further information, please contact Hill’s Pet Nutrition, Inc. at 1-800-445-5777 Monday-Friday during the hours of 7am-7pm (CT).

About Hill’s Pet Nutrition
Hill’s Pet Nutrition Inc. manufactures Hill’s® Prescription Diet® brand pet foods, therapeutic pet foods available only through veterinarians, and Science Diet® and Ideal Balance™ brand wellness pet foods sold through veterinarians and pet specialty retailers. Founded more than 70 years ago with an unparalleled commitment to pet well-being, Hill’s’ mission is to help enrich and lengthen the special relationships between people and their pets. For more information about Hill’s, our products and our nutritional philosophy visit HillsPet.com, or visit us on Facebook, keywords “Hill’s Pet Nutrition.”

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Gluten Free Snack Crackers

Glutino Voluntarily Recalls Glutino Rosemary and Olive Oil Snack Crackers (4.25 oz. and 20 oz.) Because of Possible Health Risk
Contact:
Consumer:
(201) 421-3970

FOR IMMEDIATE RELEASE – Paramus, NJ – June 2, 2014 – Glutino, a division of GFA Brands, Inc. based in Paramus, NJ, is voluntarily recalling Glutino Rosemary and Olive Oil Snack Crackers. The recall is being initiated because the seasoning supplier, Kerry Ingredients, recalled the seasoning blend due to possible Salmonella contamination.

Glutino Rosemary and Olive Oil Snack Crackers products with “Best By” date of October 26, 2014 are being recalled because they have the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.

The recalled Glutino Rosemary and Olive Oil Snack Crackers were distributed nationally through retail and warehouse club stores. The product affected is sold in a 4.25 ounce and a 20 ounce opaque white box with a “Best By” date of October 26, 2014 stamped on the top of the box. The recall is limited to the Glutino Rosemary and Olive Oil Snack Crackers and does not extend to any other Glutino products.

Gluten Free Rosemary & Olive Oil Snack Crackers

The affected Glutino UPCs are:

6 78523 03861 1
6 78523 03863 5
No illnesses have been reported to date with consumption of the Glutino Rosemary and Olive Oil Snack Crackers. Customers who purchased this item are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 201-421-3970 or visit http://www.glutino.com.
About Glutino

Since 1983, Glutino has been a trusted pioneer and leader in the gluten free category. Glutino offers a wide variety of great-tasting, gluten free foods consumers can trust. Glutino® products are available in the US and Canada at local supermarkets, natural and organic retailers. For more information on Glutino, visit http://www.Glutino.com. Glutino is a division of GFA Brands, Inc., a Boulder Brands company.

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Baptista’s Bakery Inc. Issues Voluntary Recall for LiveGfree
Rosemary and Olive Oil Multiseed Snack Crackers

Contact
Consumer:
414-409-2123

FOR IMMEDIATE RELEASE – June 2, 2014 – Baptista’s Bakery, Inc. is voluntarily recalling 4,339 cases of LiveGfree Gluten Free Rosemary and Olive Oil Multiseed Crackers with a best if used by date of 11-24-14 because they contain a seasoning that is being recalled by Kerry Ingredients. Kerry Ingredients is recalling the seasoning due to possible health risks related to Salmonella contamination.

The affected products were distributed nationally:

  • LiveGfree 4.25 oz Gluten Free Rosemary and Olive Oil Multiseed Crackers: Best By Date 11-24-14

Consumers who have purchased this item are urged to not eat the product, and to dispose of it or return it to the store where it was originally purchased.

No illnesses have been reported. The recall is being initiated as part of the Kerry Ingredients recall of its seasonings that contained an ingredient that tested positive for Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses. Baptista’s Bakery became aware of this issue when Kerry Ingredients contacted Baptista’s to inform them that Kerry may have shipped an ingredient that may be contaminated with Salmonella. Baptista’s Bakery, Inc. is working closely with FDA on this issue. “Ensuring the premium quality of our products is our highest priority,” said Tom Howe, President, Baptista’s Bakery, Inc. “We stand behind the safety and integrity of our products and are issuing this recall in order to afford maximum protection of our customers”, confirmed Laura Villarreal, Director of Quality Assurance.

Customers with questions or concerns may contact Laura Villarreal at 414-409-2123 between 8:00 am and 6 pm CST.

[Courtesy: FDA]

2014 The NW Fire Blog | Twitter: @nwfireblog | Email: nwfireblog@comcast.net | Facebook: The NW Fire Blog

 

FOOD RECALL: Pet Food Due to Possible Salmonella Contamination

Contact
Consumer:
1-888-765-4190

Media:
419-394-3374
800-780-0874
FOR IMMEDIATE RELEASE – February 5, 2014 – Pro-Pet LLC, St. Marys, Ohio, has initiated a voluntary recall of a limited number of Dry Dog and Cat Foods for possible Salmonella contamination. A single field test indicated products manufactured during a two day period, on a single production line may have the potential for Salmonella contamination. Pro-Pet LLC is voluntarily recalling the potentially impacted products made during this timeframe. There have been no reports of illness related to this product to date.

Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

 

Product Best By Lot Code UPC Number
40 lb Hubbard Life Happy Hound Dog Food 05 06 14 096 13 SM L2 2A 1219033878
40 lb Hubbard Life Happy Hound Dog Food 05 06 14 096 13 SM L2 1A 1219033878
18 lb Hubbard Life Cat Stars Cat Food 05 06 14 096 13 SM L2 1A 1219033873
40 lb Hubbard Life Maintenance Dog Food 05 06 14 096 13 SM L2 2A 1219033875
15 lb Joy Combo Cat Food 05 06 14 096 13 SM L2 1A 7065407721
40 lb Joy Combo Cat Food 05 06 14 096 13 SM L2 1A 7065407713
40 lb Joy Combo Cat Food 05 06 14 096 13 SM L2 2A 7065407713
20 lb QC Plus Adult Dog Food 05 07 14 097 13 SM L2 2A 2351780103
40 lb QC Plus Adult Dog Food 05 07 14 097 13 SM L2 2A 2351780104
40 lb QC Plus Adult Dog Food 05 07 14 097 13 SM L2 1A 2351780104

These products were distributed through select retailers, distributors and on-line consumer purchases in Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia

No other products/lot numbers are affected by this recall.

Customers should immediately discontinue use of any impacted product and contact Pro-Pet at 1-888-765-4190 for disposition.

For more information on the recall, customers can contact the customer service line for Pro-Pet at 1-888-765-4190. Customer service representatives will be available Monday through Friday 8 am to 5 pm CT.

2014 The NW Fire Blog

FDA: Pet Food Recall Issued

Bravo! Recalls 2 lb Tubes of Chicken Blend-Raw Frozen Food Diet for Dogs and Cats (One Lot Code) Because of Possible Salmonella Health Risk

 

Contact:
Consumer:
David Bogner
866-922-9222
E-mail: info@bravorawdiet.com
 

FOR IMMEDIATE RELEASE – March 13, 2013 – Bravo! is voluntarily recalling its 2 lb tubes of Bravo! Raw Food Diet Chicken Blend for Dogs and Cats, product code: 21-102, batch ID code 6 14 12, because it has the potential to be contaminated with Salmonella.

The recall involves 2 lb. Bravo! Chicken Blend frozen raw diet tubes (chubs) made on June 14, 2012 only; no other products or sizes are involved. The recalled product should not be sold or fed to pets. This batch tested negative by a third party independent laboratory prior to release for distribution to consumers, however routine testing by the Minnesota Department of Agriculture of product collected from a single retail location tested positive for presence of salmonella. While the testing discrepancy is unclear, in an abundance of caution Bravo is issuing this recall.

The company has received no reports of illness in either people or animals associated with this product.

The recalled product is distributed nationwide to distributors, retail stores, internet retailers and directly to consumers, and can be identified by the batch ID code 6 14 12 located on the white hang tag attached to the bottom of the plastic film tube.

Pet owners should return unopened frozen tubes of food to the store where purchased for a full refund. Pet owners should dispose of opened tubes of product in a safe manner (example, a securely covered trash receptacle) and return the washed plastic batch ID tag to the store where purchased for a full refund.

Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets. A list of safe pet food handling tips can be found at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048182.htm.1

For more information on the Bravo recall, please visit www.bravorawdiet.com2, or call toll free (866) 922-9222 Monday through Friday 9:00 am to 5:00 pm (EST).

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