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Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector

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Mylan N.V. today announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

U.S. Impacted Lots:

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM087 October 2017

Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.

Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.

To return your product please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.

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.

This voluntary recall is being conducted with the knowledge of FDA.

Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.

More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.

Please see the full Prescribing Information and Patient Information.

County/City release Courthouse and Administrative Space Project RFI

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FLAGSTAFF – Coconino County and the City of Flagstaff are issuing a Request for Information (RFI) to seek ideas and opportunities related to the development of a City and County downtown courthouse and additional administrative spaces.

The RFI is the first of a multi-step process. The RFI asks the public to help bring forth ideas. Area residents, downtown business owners, community partners, developers, contractors and other stakeholders are encouraged to participate.

“This is an open and transparent process that will allow the private sector, community and partners to weigh in on the Courthouse Development and Administrative Space Project,” stated Chairwoman of the Board of Supervisors Liz Archuleta. “We want to make sure every step is deliberately taken to ensure the needs of our community are met in any courthouse development project. Coconino County has had success with previous public/private partnerships. This could be another opportunity to optimize resources on behalf of our mutual constituents.”

Coconino County and the City of Flagstaff are considering new approaches to leverage existing assets and engage the private sector for ideas. The collaboration between the County and the City for the project is intended to save taxpayer dollars and increase parking in downtown Flagstaff.

In November 2016 City of Flagstaff voters passed Prop 412 which authorized $12 million in bonds to construct a courthouse and parking facility. Mayor Coral Evans said, “We are extremely excited to move this process forward and implement the voters’ decision to build a new courthouse and parking garage. Joint collaboration between the City and County enhances this endeavor and our ability to utilize resources collectively creates cost efficiency.”

There will be a pre-submittal briefing tour at 10 a.m., April 8 at the Coconino County Administrative Center, 219 East Cherry Avenue. All RFI information is due at 2 p.m., Wednesday, May 3 at the Coconino County Purchasing Office, 219 E. Cherry Ave. Flagstaff. The RFI will not be an obligation on the part of the partnership to enter into any agreement.

For more information contact the Coconino County Purchasing Office at 928-679-7191 and visit www.coconino.az.gov/Bids.aspx and follow the directions to submit a response to the Request for Information (RFI 2017-01) Optimization of the Court Expansion Facility and Private Sector Development Opportunity.

JLUS Policy Committee awarded Department of Defense Joint Land Use Study Grant

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FLAGSTAFF – The Department of Defense (DoD) Office of Economic Adjustment has awarded a $532,700 grant to Coconino County for a Joint Land Use Study (JLUS), which provides recommendations for land uses that are compatible with the missions of military installations while also supporting economic development and community values.

In June 2016, Coconino County convened a JLUS Policy Committee, chaired by Flagstaff City Councilmember Celia Barotz, with stakeholders from the City of Flagstaff, Coconino County, State of Arizona Departments, U.S. Forest Service, Arizona Army National Guard Camp Navajo, U.S. Naval Observatory Flagstaff Station, Navajo Nation, Hopi Tribe, Northern Arizona University, Economic Collaborative of Northern Arizona (ECoNA), Lowell Observatory, developers, and local businesses and civic associations. The Policy Committee met several times to determine the scope of study for the grant application.

“I extend my sincere thanks to Coconino County for taking the lead on this important planning effort; the stakeholders who are members of the Policy Committee for engaging in this effort thus far; and the DoD Office of Economic Adjustment for awarding the grant for the study. As the City of Flagstaff and Coconino County grow, it’s essential that we plan now to try and minimize future land use conflicts around our local military installations,” said JLUS Policy Committee Chair Flagstaff City Councilmember Celia Barotz.

“We appreciate that the DoD Office of Economic Adjustment saw the value in this project and awarded this grant,” said Supervisor Ryan. “This grant will allow the Policy Committee to study the best uses for this land and determine what is in the best interest of our community while fulfilling the missions of our military installations.”

The grant will be used to hire a consultant who will conduct the study that will identify land uses that are compatible with United States Naval Observatory, Flagstaff Station and the Arizona National Guard Camp Navajo in Bellemont. Additional objectives of the study include increasing public awareness of the military missions and improving communications between the military and community stakeholders.

“This is a fine example of many partners coming together to work on a joint project. I thank my colleagues Supervisors Art Ryan and Art Babbott, and all the staff for their effort on this project. Their hard work and determination in assembling the JLUS Policy Committee and drafting the application made this grant possible,” stated Coconino County Board of Supervisors Chairwoman Liz Archuleta. “I look forward to the process unfolding and the final recommendations.”

Conagra Brands Recalls Hunt’s Chili Kits

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Conagra Brands, Inc., announced today it is voluntarily recalling a limited amount of Hunt’s Chili Kits due to the potential presence of Salmonella in the chili seasoning packet contained in the kit. The chili seasoning used in the packet originated from a supplier who informed the company of the potential presence of Salmonella in a raw material used in the chili seasoning. Although no Salmonella was found in the finished product supplied to Conagra Brands, the company has decided out of an abundance of caution to recall the product.

There have been no reports of adverse reactions or injuries due to consumption of this product to date. Salmonella is a bacterium that can cause diarrhea, fever and abdominal cramps. Most individuals recover without treatment. In some cases, diarrhea may be so severe that the patient needs to be hospitalized. The elderly, infants and those with impaired immune systems are more likely to have a severe illness.

The product covered by this recall was distributed in retail stores, military commissaries and online nationwide in the U.S.; the specific product information is listed below. The product code information is stated on the bottom of the kit below the barcode. No other Hunt’s products or Conagra Brands’ products are impacted by this recall.

Item Description UPC MFG/Lot Code Best By Date
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619500 Apr 04, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534622200 May 01, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619600 Apr 05, 2018

Consumers who have purchased this item are advised not to consume it and return it to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Affairs hotline at 1-800-921-7404, open 9 am through 5 pm CDT, Monday through Friday.

2017 Outdoor Expo one for record books

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PHOENIX — For the second straight year, the Arizona Game and Fish Department’s Outdoor Expo – the state’s largest free outdoor expo – has set an all-time attendance record.

The event, presented by Shikar Safari Club International, drew 46,600 visitors over the March 25-26 weekend at the Ben Avery Shooting Facility in Phoenix. That shattered the previous two-day weekend record of 41,100, set in 2016.

A “Youth Day” experience also was offered March 24 that attracted 1,800 students, teachers and chaperones, bringing this year’s three-day total to a record 48,400. The previous record was 48,000 in 2015.

“We’re not aware of any other event of this scale that combines conservation, recreation and industry into such a welcoming environment for the public,” said Scott Lavin, the department’s wildlife recreation branch chief. “This is where people can find plenty of hands-on activities, test and purchase the latest equipment and products, and connect with social organizations that can provide countless ‘next step’ experiences to support their outdoor passions.”

The expo features everything from wildlife exhibits and family fishing tanks, to kayaking at the 90,000-gallon “Lake Paddlemore” and trying out firearms in a safe, controlled environment on the range. There also are many opportunities for visitors to check out more than 150 exhibitors, including sportsmen and conservation organizations, recreational shooting groups, government agencies and commercial vendors of outdoor products and services.

Since 2007, the expo traditionally has been scheduled for the last weekend in March (but not to conflict with Easter weekend). This year marked the 10th anniversary of the “Outdoor Expo.” The event previously was known as the “Hunting and Shooting Showcase” from 2004 to 2006.

For the third straight year, Shikar Safari Club International was the presenting sponsor. Gold sponsors were OneAZ Credit Union and Shooter’s World/Daniel Defense. Silver sponsors were Sportsmen’s Alliance Foundation, Sportsman’s Warehouse, FN America, Cabela’s and Target Factory. Bronze sponsors were the Mule Deer Foundation and Lincoln Property Company.

“We are grateful to our sponsors and 155 exhibitors who support this event and provide us with an opportunity to introduce ourselves as a department and share our mission with the public at no charge,” Lavin said.

Next year’s expo is scheduled for March 24-25, 2018, at the Ben Avery Shooting Facility. Visit www.azgfd.gov/expo for more information.

“Shot Heard ‘Round the World Day” is April 19

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PHOENIX — The world-class Ben Avery Shooting Facility will be the place to be Wednesday, April 19, a day when recreational shooters can join together to symbolize the first shot fired in 1775 to mark the beginning of the American Revolution, while enjoying a fun shooting event.

It will be 242 years to the day when the “Shot Heard ‘Round the World” was fired in the pre-dawn light in Lexington, Mass., between the colonial militia and British army, regarded as the start of the American Revolutionary War.

The inaugural event, being promoted at public shooting ranges across the nation, also will provide an opportunity to increase participation and boost the economic benefits that shooting sports provide. As recreational shooters check in and visit BASF’s small bore range from 7 a.m. to 4 p.m., they will be connected to recreational shooting mentor groups and shooting industry manufacturers and retailers inside the nearby indoor air gun and archery building.

Whether or not a recreational shooter actively participates in hunting or angling, he or she contributes to the main source of funding for state wildlife conservation efforts through an excise tax placed on the purchase of shooting sports equipment and ammunition, as legislated by the Pittman-Robertson Act. Those funds also are spent on shooting sports projects, including the building of shooting ranges, and programs.

For more information about “Shot Heard ‘Round the World Day,” visit www.shotheardroundtheworldday.com.

For more information about the Ben Avery Shooting Facility, visit https://www.azgfd.com/Shooting/BASF/.

ADOT crews now can clear travel lanes of minor wrecks

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PHOENIX – With a goal of keeping drivers and first responders safe and traffic flowing, Arizona Department of Transportation personnel are now authorized to clear or order removal of vehicles that are involved in minor crashes.

When incidents occur, ADOT coordinates with Arizona State Troopers to set up traffic control, close highways and, when necessary, arrange hazardous materials cleanup. When ADOT personnel arrive before State Troopers at the scene of a minor crash or when State Troopers ask them to do so, a new agency policy empowers them to take action to clear travel lanes.

“Quickly clearing hazards is a proven way to make everyone safer, including State Troopers, ADOT personnel and others responding,” said Brent Cain, ADOT’s director of Transportation Systems Management & Operations. “Having ADOT’s highly trained crews take action when appropriate to keep traffic moving promotes safety and reduces congestion.”

The change stems from best practices in Traffic Incident Management (TIM) strategies, including the principle of Quick Clearance.

Getting vehicles that are involved in minor crashes out of travel lanes quickly makes the roadway safer for other vehicles and emergency responders, reduces the chance of secondary crashes when traffic approaches the incident and minimizes overall traffic congestion.

State law requires drivers involved in minor crashes that don’t involve injuries to get their vehicles out of travel lanes as soon as it’s safe to do so.

State Troopers must authorize removal of vehicles involved in crashes that result in serious injuries or deaths.

Expect road work for the next four weeks on Interstate 17 between New River and Sunset Point

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Crews have completed the initial paving on Interstate 17 between New River and Sunset Point as part of a $10.8 million pavement project that began last summer. However, crews will be on site over the next four weeks as they work on sign and guardrail installations, delineators and other miscellaneous work.

Work is scheduled to occur Sunday through Thursday nights from 6:30 p.m. to 6 a.m. Drivers should anticipate north and southbound lane restrictions during work hours.

The project is scheduled to be completed by summer 2017.

Drivers should proceed through the work zone with caution, slow down and watch for construction personnel and equipment.

Overnight work on State Route 260 continues next week; crews will reduce roadway to one lane overnight

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Overnight work will continue on SR 260 in Camp Verde near Interstate 17 as crews haul excess materials. SR 260 will be narrowed to one lane from Sunday, April 2 through Thursday, April 7 between 9 p.m. and 5 a.m.

Drivers will need to allow additional travel time as they will be guided through the work zone by flagging crews.

The $62 million safety improvement project in Yavapai County will upgrade a nine-mile segment of SR 260 from a two-lane roadway to a four-lane, modern divided highway east of Cottonwood between Thousand Trails Road and the Interstate 17 junction in Camp Verde. The work is expected to take approximately 18 months to complete.

Drivers should proceed through the work zone with caution, slow down and watch for construction personnel and equipment.

ADOT works to inform the public about planned highway restrictions and closures, but it’s possible that unscheduled impacts might occur because of weather or other factors. For the most current information about highway conditions statewide, visit ADOT’s Traveler Information Site at www.az511.gov, follow ADOT on Twitter (@ArizonaDOT) or call 511, except while driving.

Mexican wolf captured in Chiricahua area of Arizona

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PHOENIX — A female Mexican wolf originating from an ongoing reintroduction effort in Mexico was captured March 26 on private ranch land in southeastern Arizona by the Interagency Field Team (IFT) and relocated to the Sevilleta Wolf Management Facility in New Mexico, where it is in good health. Management agencies in the United States and Mexico will determine the most appropriate long-term management action for this wolf.

The wolf was first sighted in the United States on March 19 by an Arizona Game and Fish Department wildlife manager and again on March 22 by ranch employees. In the latter instance, the wolf exhibited minor problem behavior by not retreating after the reporting party tried to haze it out of the area. The wolf is believed to have been traveling alone, as there have been no other wolf sightings in the area.

The wolf was initially described as wearing a GPS radio collar, and the Arizona Game and Fish Department conducted an aerial telemetry flight on March 22 to detect any signal emanating from the collar; however, no signal was detected, and the collar was later found to be non-functional.

The wolf (f1530) was born in 2016 at a captive wolf breeding facility in Cananea, Mexico, and released in October 2016 in the state of Chihuahua, Mexico, approximately 90 miles from the international border. The last collar radio transmission was Feb. 14, 2017, from 21 miles south of the international border with New Mexico.

Some area ranchers reported possible livestock depredations in the area. USDA Animal and Plant Health Inspection Service – Wildlife Services investigated eight livestock carcasses between March 22 and 27, to determine the cause of deaths. The results of the investigation confirmed that one was killed by a wolf, four died of natural causes, two died of unknown causes, and one was unable to be investigated because of its deteriorated condition.

Ranchers who experience confirmed wolf depredations can apply for compensation through the Arizona Livestock Loss Board. Additionally, area ranchers can receive funding to implement actions to minimize wolf-livestock interaction through Defenders of Wildlife and the Mexican Wolf Fund.

“We were decisive in our management actions because this wolf was young, alone, genetically important, and not affiliated with another pack,” said U.S. Fish and Wildlife Service Southwest Regional Director Benjamin Tuggle. “Future management actions may differ based on the circumstances of each scenario.”

The area where this wolf was captured is within the federal Mexican Wolf Experimental Population Area (MWEPA) in the United States. This designation was revised in 2015 and provides flexibility for managing Mexican wolves as part of an experimental population. Prior to 2015, the MWEPA extended from Interstate 40 south to Interstate 10 in Arizona and New Mexico. The 2015 revision extended the southern boundary to the United States/Mexico border to provide more management flexibility in this area.

The Fish and Wildlife Service, along with the Arizona Game and Fish Department, the Mexican government, and the states of New Mexico, Colorado and Utah, are reviewing biological information for the development of a revised Mexican wolf recovery plan. That review focuses on recovery south of Interstate 40 and into Mexico with the expectation that populations in the two countries will be connected.

Mexico has been a partner in the recovery of the Mexican wolf since the two countries established a binational captive breeding program in the 1970s to halt the extinction of the Mexican wolf. The Mexican government began re-establishing Mexican wolves back into the wild in 2011, following their elimination from the wild in Mexico in the 1980s.

The Mexican wolf recovery program is a partnership between the Fish and Wildlife Service, Arizona Game and Fish Department, White Mountain Apache Tribe, USDA Forest Service, USDA Animal and Plant Health Inspection Service – Wildlife Services, and several participating counties. The Interagency Field Team (IFT) is responsible for the day-to-day management of the Mexican wolf population and includes field personnel from several of the partner agencies.

For more information on the Mexican Wolf Reintroduction Program, visit
www.fws.gov/southwest/es/mexicanwolf or www.azgfd.gov/wolf.