Category Archives: National

Pile Burns to Continue on South Side of Williams Ranger District

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WILLIAMS – Fire crews will begin burning an additional 500 acres of hand piles scattered across the southern half of the Williams Ranger District beginning Monday of this week.

Inclement weather bringing moisture has presented favorable conditions to continue reducing fuel loads at various locations that include Coleman Lake, Sevier Flat, and Jackass Flat. Conditions will be evaluated daily before burns are implemented to ensure desirable effects and management objectives are being met. Fire managers will conduct operations incrementally at different locations throughout the week.

Smoke production is expected to be minimal with very short duration and disperse quickly to the northeast. No overnight impacts are expected.

Visitors are always reminded to use caution when traveling in the vicinity of prescribed fires, as firefighters, fire-related traffic and smoke may all be present.

All prescribed fires are subject to approval by the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division and to view prescribed burn authorizations for any given day, visit www.azdeq.gov/programs/air-quality-programs/smoke-management

Notifications of upcoming prescribed fires are provided regularly throughout the year. This information can be found at the following sources:

· Fire Information Recorded Hotline: 928-635-8311
· Twitter: www.twitter.com/KaibabNF (Text ‘follow kaibabnf’ to 40404 to receive text messages.)
· Kaibab Facebook: www.facebook.com/KaibabNF
· Kaibab website “Recent News”: www.fs.usda.gov/kaibab
· Kaibab South Zone Rx Fire: inciweb.nwcg.gov/incident/5160/

Congressman Paul Gosar calls for arrest of illegals at State of Union Address

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WASHINGTON, D.C. – Today, U.S. Congressman Paul A. Gosar, D.D.S. (AZ-04) contacted the U.S. Capitol Police, as well as Attorney General Jeff Sessions, asking they consider checking identification of all attending the State of the Union address and arresting any illegal aliens in attendance. Additionally, Congressman Gosar asked that they arrest those using fraudulent social security numbers and identification to pass through security.

“Of all the places where the Rule of Law needs to be enforced, it should be in the hallowed halls of Congress,” said Congressman Gosar. “Any illegal aliens attempting to go through security, under any pretext of invitation or otherwise, should be arrested and deported.”

Amateur radio satellite Fox-1D (AO-92) now commissioned

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AMSAT Vice President-Operations Drew Glasbrenner, KO4MA, has
declared that Fox-1D (AO-92) is now open for general Amateur Radio use. That word followed an announcement from AMSAT Vice President-Engineering Jerry Buxton, N0JY, that AO-92 had been commissioned and formally turned over to AMSAT Operations.

Initially, the U/v FM transponder will be open continuously for 1-week. After that, operation will be shared among the U/v FM transponder, L-Band Downshifter, Virginia Tech Camera, and the University of Iowa’s High Energy Radiation CubeSat Instrument (HERCI).

AO-92 was launched from India on January 12. For the past 2 weeks, the AMSAT Engineering and Operations teams have been testing the various modes and experiments on board. Testing has shown that both the U/v FM transponder and L-Band Downshifter are working well. The Virginia Tech camera has returned photos of Earth and data from HERCI has been successfully downlinked.

AMSAT thanked the 178 stations around the world that used FoxTelem to collect telemetry and experiment data from AO-92 during the commissioning process.

AMSAT News Service, AMSAT-BB, AMSAT’s Twitter account (@AMSAT), the
AMSAT-NA Facebook group, and the AMSAT website will report any updates.

Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

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Tigard, OR – Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Patients may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, bleeding, ulceration, or perforation of the stomach or the intestines. The populations most at risk are: children, pregnant women, nursing mothers, and surgical patients. Magno-Humphries Laboratories, Inc., has not received any reports of adverse events related to this recall to date.

Basic Drugs Brand Senna Laxative, 8.6mg Sennosides, tablet is used as a laxative (natural) to relieve constipation and is packaged in 100-count bottles, with an outer neck seal and a child resistant cap, with Lot#352300, EXP: 01/19 printed on the bottom of the bottle. Basic Drugs Brand Senna Laxative tablets were distributed Nationwide in the USA to secondary distributors, retail pharmacies and via the internet.

Magno-Humphries Laboratories, Inc., has notified its distributor by e-mail and is arranging for the return of all recalled products. Consumers, distributors or retailers that have Basic Drugs Brand Senna Laxative Lot#352300 which are being recalled should stop using the product and return it to Magno-Humphries Laboratories, Inc. or their distributor.

Consumers with questions regarding this recall can contact Magno-Humphries Laboratories, Inc. by (503) 684-5464, (800) 935-6737 [state days of the week] between 9am to 5pm PT or by e-mail at info@magno-humphries.com. Consumers 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 www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 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.

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure

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The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers a treatment (i.e. a shock) to restore the patient to a normal heart rhythm.

FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver therapy appropriately when needed.

Ideally, the LifeVest monitors the patient’s heart, delivering a “treatment shock” as needed to restore the patient’s heartbeat to a normal rhythm. However, FDA is aware that in certain cases the LifeVest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. The “Message Code 102” alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.

To date, FDA is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. According to Zoll, as of November 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the U.S. About 0.1% of the total devices distributed have displayed Message Code 102, which should only be remedied by immediate replacement of the device.

The FDA will continue to work with Zoll to monitor LifeVest 4000 devices for any adverse events related to Message Code 102 or a failure to deliver treatment. The FDA will also continue to work with Zoll to identify a permanent solution to the Message Code 102 issue, and will keep the public informed as new information becomes available.

RECOMMENDATION:
For Health care providers –

  • Train patients prescribed use of the Zoll LifeVest 4000 on how to identify the “Call for service, Message Code 102” alert. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The alert will read “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” and will allow the patient to tap “OK” to return to normal operation.
  • Inform patients to respond to the “Call for service, Message Code 102” alert on the LifeVest 4000 screen by contacting Zoll immediately. Message Code 102 may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed. Zoll will replace the patient’s device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Reinforce initial LifeVest 4000 training, explaining that the device can display messages on the screen and play audio alerts that require the patient to take action. If Message Code 102 does not appear on the device screen, the patient should continue to use the LifeVest 4000 as prescribed, and read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

For Patients and Caregivers:

  • Contact Zoll immediately if “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” appears on your LifeVest 4000 screen. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The Message Code 102 alert will also allow you to tap “OK” to return to normal operation.
    > However, the “Call for service, Message Code 102” alert may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed.
    > Zoll will replace your device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Continue to use your LifeVest 4000 as prescribed by your physician and as instructed during your initial training if the “Call for service, Message Code 102” alert is NOT displayed on your device screen. You should continue to read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 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

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

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Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.

NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.
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Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter – Anaphylaxis and Other Serious Hypersensitivity Reactions

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Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting—some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Symptoms of anaphylaxis can include wheezing or difficulty breathing, swelling of the face or throat, hives or flushing, itching; abdominal cramping, abdominal pain or vomiting, back pain or chest pain, hypotension or shock.

BACKGROUND: Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.

Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,

  1. administration of Varubi (rolapitant) injectable emulsion should be stopped immediately.
  2. appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
  3. Varubi (rolapitant) injectable emulsion should be permanently discontinued.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  1. Complete and submit the report Online: www.fda.gov/MedWatch/report
  2. Download form or call 1-800-332-1088 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

See the Health Care Provider Letter for important prescribing information to reflect the new safety information.

Forest Service hiring for temporary positions for 2018 field season

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From November 1-9, the Forest Service, U.S. Department of Agriculture, will be accepting applications for temporary spring and summer jobs in Arizona and New Mexico.

More information on temporary employment in the Forest Service’s Southwestern Region can be found at Centralized Temporary Hiring Outreach, including a link to the 2018 Outreach Notice with job listings for the Southwestern Region.

Applications must be submitted on www.USAJOBS.gov. Interested applicants are encouraged to create a profile within USAJOBS prior to the open vacancy announcement period.

Positions in the Southwestern Region of the Forest Service are available in multiple fields, including wildland fire, engineering, visitor services, archaeology, recreation management, timber management, range management, wildlife program management, business management, and other fields in natural resource management.

Positions will be filled at various locations within any of the 11 national forests in Arizona and New Mexico and the three national grasslands in New Mexico, Oklahoma, and west Texas.

To learn more about national forests and national grasslands in the agency’s Southwestern Region, please visit http://www.fs.usda.gov/r3.

The Forest Service is an equal opportunity employer. The mission of the Forest Service is to sustain the health, diversity, and productivity of the nation’s forests and grasslands to meet the needs of present and future generations.

SCA Pharmaceuticals Issues Voluntary Nationwide Recall

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SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination.

Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue, but out of an abundance of caution, is voluntarily initiating this recall.
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Infant Sleep Positioners: FDA Warning – Risk of Suffocation

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ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.

BACKGROUND: The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.

  • NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
  • NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
  • ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
  • ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”

ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.

BACKGROUND: The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.

NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 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