Category Archives: National Government

Abbott’s Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance

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Abbott’s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.

All recalled products have a label that includes the Abbott’s Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.

The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott’s Compounding Pharmacy is voluntarily recalling all sterile compounded products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious and potentially life-threatening infections.

To date, Abbott’s Compounding Pharmacy has not received any reports of any adverse effects or injuries, and the recalled products were distributed exclusively within the state of California directly from its Berkeley, California pharmacy location.

Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.

Customers with questions regarding this recall can contact Abbott’s Compounding Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm at (510) 548-8777, or email its media representative.

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.

  1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  2. 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
  3. For reporting animal adverse drug events: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Abbott’s Compounding Pharmacy deeply regrets any disruption that this voluntary recall and temporary suspension of Sterile compounding services have on its Customers, but notes that safety and quality are its primary concerns.

Blendtech Issues Allergy Alert on Undeclared Milk Allergen in Uncle Buck’s Fish Batter Mix – Original

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ucm482079BlendTech Inc of Wichita, KS, is voluntarily recalling one lot of Uncle Buck’s Fish Batter Mix – Original due to the presence of an undeclared milk ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Batter Mix was distributed in Bass Pro Shops stores nationwide and through mail order.

The affected product is packaged in a 22 ounce, yellow plastic bottle with black cap, UPC 9222972528, and marked with lot #09241505 on the bottom of the bottle.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after BlendTech discovered product containing milk was distributed in packaging that did not reveal the presence of milk.

Consumers who have purchased the affected product are urged to discard it. Consumers who would like replacement or have questions may contact the company at 1-844-265-7354 or at 1-316-941-9660, Monday – Friday 8:00AM to 4:30PM CST.

Fredonia, Kanab Elementary Schools receive grant for fourth graders

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FREDONIA — Fredonia Elementary School and Kanab Elementary School are each one of 186 sites recently selected to receive a field trip grant from the National Park Foundation for the 2015-2016 school year in support of the White House youth initiative Every Kid in a Park.

As the official charity of America’s national parks, the foundation officially made the announcement in December. A full list of grantees and their projects may be found at http://www.nationalparks.org/ook/every-kid-in-a-park. Leading up to this year’s 100th birthday of the National Park Service (NPS), President Obama announced the Every Kid in a Park initiative in 2015 as a call to action to get fourth graders outdoors spending time with nature, family and friends.

Specific to fourth graders, the Forest Service and other land and resource management agencies already have conservation education programs in place to connect 9-to-11 year-old children to learn about landscapes surrounding their homes and schools. Every Kid in a Park aligns well with these education programs.

Shortly after the program’s announcement in September, representatives from the North Kaibab Ranger District of the Kaibab National Forest, Bureau of Land Management Kanab Field Office, Grand Staircase Escalante Partners, and the National Park Service’s Pipe Spring National Monument partnered together to visit fourth graders at schools in Fredonia, Ariz., Colorado City, Ariz., Centennial Park, Ariz., Hildale, Utah, and Kanab, Utah, in order to generate support for the program.

During these visits, each fourth grade student was given a one-year Every Kid in a Park pass, providing the student and anyone accompanying them in the vehicle with free entry to hundreds of parks, forests and sites across the country. In addition to the Every Kid in a Park pass, the National Park Foundation awarded grants to both schools in December. Grant funding will provide field trip opportunities for each fourth grade class to participate in three field trips during the 2015-2016 school year; one each hosted by the North Kaibab Ranger District, Bureau of Land Management Kanab Field Office, and Pipe Spring National Monument. The funding will be used to provide schools with funding for transportation, learning materials and meals.

“We are excited to have this opportunity available to our fourth graders here in Kanab and Fredonia,” said Wildlife Biologist Lisa Church, Bureau of Land Management, Kanab Field Office. “Anytime we can motivate students and teachers to get outside and enjoy nature, it helps the children better understand how they can care for and protect the natural treasures that we have right here in our own backyards for future generations to also someday appreciate.”

Church assisted with the grant application process, resulting in $3,700 being awarded to the Kanab fourth-grade class and $9,000 to the Fredonia fourth-grade class.

“The Every Kid in a Park program has been a great benefit for our students, especially when you consider our location,” said Fredonia Elementary School Principal Joe B. Wright. “Being surrounded by multiple parks and forests, this program provides even greater accessibility for our 4th graders and their families. We sincerely appreciate the federal employees who have spent time working cooperatively with Fredonia Elementary School. Our students are very excited about the grant funded field trips that will be coming up in the next few months.”

National Park Foundation grants have made it possible for more than 400,000 students (including this year’s grantees) to visit national parks and other public lands and waters.

“It is inspiring to see the National Park Foundation and many other partners step up to support our goal of getting fourth graders and their families into parks, public lands and waters that belong to all Americans,” said U.S. Secretary of the Interior Sally Jewell. “These generous grants will ensure children across the country have an opportunity to experience the great outdoors in their community while developing a lifelong connection to our nation’s land, water and wildlife.”

Women in Wildland Fire boot camp opening soon

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The USDA Forest Service Southwestern Region is seeking a small group of career focused women to be on-call Wildland Fire Fighters for the 2016 fire season. These on-call positions will provide support to wildland fire operations over the summer when needed and can help pave the way for future employment and career advancement inside of the Forest Service.

If you are selected for this opportunity, your first assignment will be a Women in Fire Boot Camp. The Boot Camp will provide comprehensive, formal physical wildland fire training and orientation. Upon successfully completing this training each person will receive a Wildland Fire Fighter certification and protective gear.

If you or someone you know may be interested in this opportunity, please carefully review the attached documents for additional information and instructions. The application deadline is Feb. 5, 2016.

The Arizona contact for the Women in Wildland Fire Boot Camp is:

Cory Ball
(928) 477-5024
cjball@fs.fed.us

Visitor center hosts “Kaibab National Forest, A Historic Snap Shot” display

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WILLIAMS — The Williams Visitor Center is hosting a showing of historical images, maps and documents of the Kaibab National Forest from the late 1880s to 1960 as part of the “Kaibab National Forest, A Historic Snap Shot” visual display, which will be available for public viewing through this summer.

This photo and map display represents the historic evolution of public land from the early Grand Canyon Forest Reserve to the Grand Canyon Monument, the Tusayan National Forest, and then eventually the Kaibab National Forest. The photos, which were taken on both sides of the Grand Canyon, are a representative sample of historic activities and places on the national forest. The maps show a stark contrast in boundaries from the early forest reserve to the 1949 version of the Kaibab National Forest. Display visitors will also note additional changes in forest boundaries even after 1949.

“The historic development of the Kaibab National Forest has played a significant role in the overall history of the City of Williams and our surrounding communities. But few have looked at local history from the perspective of the Forest Service,” said Margaret Hangan, heritage program manager for the Kaibab National Forest. “Therefore, the emphasis of this display is to show how the identity and function of the Kaibab National Forest have shaped our region using the forest’s own historic photos and maps to tell the story.”

In 2009, the Kaibab National Forest and Williams Public Library formed a partnership to preserve historic images and documents of the City of Williams and the surrounding area. To date there are more than 2,464 photos, documents and oral histories in the collection, and new collections are always being identified. The collection boasts items representing iconic places and themes such as “the Mother Road” Route 66, cattle and sheep ranching, logging and the timber industry, railroads and more. In 2012, 127 of the collection’s images were posted online as part of the Arizona Memory Project.

The collection, which is entirely digital, is stored on a computer dedicated to the project at the Williams library and is made available to the public free of charge. The purpose of the project is to preserve these precious treasures of the past and to make them available to the public for historic research. Hangan and Williams Public Library director Andrea Dunn have led the multi-year effort to create what is now an indispensable resource for learning about the history of the local area.

The Williams Visitor Center is located at 200 W. Railroad Ave. in Williams.

Tree marking to begin on Williams Ranger District

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WILLIAMS — Timber and silviculture staff on the Williams Ranger District of the Kaibab National Forest will begin tree marking operations next week and continuing through the spring, between Forest Road 141 (Spring Valley Road), and Forest Road 76 in advance of eventual tree thinning operations to improve forest health conditions.

The area to be marked is part of the 4,400-acre Moonset Task Order, which will eventually be issued for treatment under the 1st Four Forest Restoration Initiative (4FRI) Environmental Impact Statement. Active forest restoration work will occur once the task order has been issued to a contractor, which is expected in 2017. In the meantime, residents and visitors to the area can expect to see trees and internal boundaries marked with orange paint, which will eventually serve as visual guidance to the contractor regarding Forest Service expectations for treatment.

A portion of the tree marking operations will take place on National Forest land that borders private property. Land owners in these areas may notice an increased number of Forest Service personnel and vehicles in the area over the next few months while tree marking operations are completed.

The objectives for treating the area within the Moonset Task Order are to reduce fuel loading and the potential for future high-intensity wildfires and to improve wildlife habitat and overall forest health.

The goal of the 4FRI is to accelerate the pace and scale of restoration within 2.4 million acres of ponderosa pine forest in northern Arizona to increase resilience and proper functioning. Restoring this fire-adapted ecosystem is accomplished with a suite of restoration activities – from watershed maintenance and habitat improvements to prescribed burning and thinning.

Access gates to close near Spring Valley Cabin due to winter conditions

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Recreation staff for the Williams Ranger District of the Kaibab National Forest will be closing three road access gates near Spring Valley Cabin Thursday due to winter weather conditions and safety concerns.

The first gate to be closed is near the intersection of forest roads 141 and 76, and the second is farther in on Forest Road 76 as part of the popular Spring Valley Cross-Country Ski Trail. The third gate is also located on Forest Road 76, 1-mile north of Forest Road 58 (Pipeline Road). The gates could remain closed until early spring, depending on weather conditions.

Spring Valley Cabin remains open and available for rental by members of the public through the Arizona “Rooms with a View” Cabin Rental Program. Those reserving the cabin while the gates are closed will have to access it by hiking, snowshoeing or cross country skiing into the area.

Additional information regarding the Spring Valley Cross-Country Ski Trail can be found at: www.fs.usda.gov/recarea/kaibab/recreation/wintersports/recarea/?recid=43349&actid=91. Other nearby winter sports opportunities can be found at: www.fs.usda.gov/activity/kaibab/recreation/wintersports.

Information on Spring Valley Cabin and how to reserve it can be viewed at: hwww.fs.usda.gov/recarea/kaibab/recreation/camping-cabins/recarea/?recid=11662&actid=101.

Be Prepared Before Going into the Backcountry and Understand Avalanche Hazards

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Sunday Benham Trail 2015-12-13 007FLAGSTAFF — The Coconino County Sheriff’s Office and the Coconino National Forest are warning backcountry mountain travelers to be alert for potential avalanche hazards on the San Francisco Peaks. The early season snowpack, coupled with recent clear and cold nights, wind events, and a large amount of new snow could produce hazardous conditions in the backcountry. This includes the side country bordering the Arizona Snowbowl Ski Area.

Avalanche mitigation and patrolling is conducted within the boundaries of the Arizona Snowbowl, but there is no avalanche control or routine patrolling in the forest outside of the Snowbowl. Those traveling into the backcountry need to be prepared for and understand the conditions prior to venturing out.

Avalanches most commonly occur during a storm or within 24 hours of the storm ending. However, unstable conditions may persist long beyond that timeframe. Backcountry travelers need to understand the conditions and the warning signs of avalanche activity.

People venturing into mountainous terrain should carry avalanche rescue equipment such as a shovel, avalanche rescue beacon, avalanche probe, and winter survival gear. Good wilderness navigation and route finding skills are essential. Be prepared for travel and emergencies in the remote winter mountain environment where rescue is not immediate. Do not travel alone, and always leave a detailed trip plan with a responsible person. It is important to review recent weather reports and forecasts as well as driving conditions prior to and during your trip. Carrying a cell phone is recommended; however, it may not always work in backcountry locations and should not substitute for good judgment and preparation.

While there is no avalanche forecasting center for the San Francisco Peaks, the backcountry community can obtain a snowpack summary from the Kachina Peaks Avalanche Center at www.kachinapeaks.org and see observations by other backcountry travelers. Natural avalanche activity had been reported on the San Francisco Peaks prior to this current storm. In addition to snow observations, the Kachina Peaks Avalanche Center provides educational materials on the website as well as sponsoring Introduction to Avalanche seminars and more in depth avalanche field training. The next Introduction to Avalanche seminar will be on January 15th at 6:00 pm at Aspen Sports in downtown Flagstaff.

Winter backcountry travel into the Kachina Peaks Wilderness Area from Arizona Snowbowl and Snowbowl Road requires an annual backcountry permit. This includes the parking areas at FR 522 and Lamar Haines Wildlife Area.

Backcountry permits are available for free in Flagstaff at the Peaks Ranger Station, 5075 N. Highway 89, and the Coconino National Forest Supervisor’s Office, 1824 S Thompson St. Permits also will be available at Arizona Snowbowl’s Agassiz Lodge on weekends during business hours.

SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo

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Dallas, TX, SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.com.

SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Consumers, distributors, retailers that have Smart Lipo which is being recalled should stop using the recalled product and asked to please dispose it.

Consumers with questions regarding this recall can contact SmartLipo365 by 1-(800)-547-6365 or info@smartlipo365.com on Monday through Friday from 10 A.M. to 5 P.M. (Central time). 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.

Kaibab National Forest announces release of wildland fire video

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firevideo-1WILLIAMS — The Kaibab National Forest is announcing the release of an informational video explaining the importance of wildland fire in the ecosystems of northern Arizona from the perspectives of various natural and cultural resource specialists.

Over the last decade, the Kaibab has managed both wildfire and prescribed fire to treat approximately 300,000 acres for a variety of objectives. That work wouldn’t have been possible without employees from all program areas actively engaging in the management of fire across the landscape, according to Kaibab fire staff officer Art Gonzales. Because of those ongoing efforts, Gonzales thought it important to highlight a part of the wildland fire world that most people never get to see.

“Typically, most fire videos provide a fire management officer, fuels specialist or fire ecologist perspective on why we believe fire across the landscape is essential for a number of reasons,” Gonzales said. “I wanted to take this video in a new direction, a direction in which those folks who are often the critical link in a successful program do not remain behind the scenes or go unnoticed. I was looking for a video about fire but from a non-fire perspective.”

To that end, Gonzales teamed with the Southwest Fire Science Consortium and producer Josh McDaniel to create a 10-minute video entitled “Keeping Fire on the Ground: Resource Specialist Perspectives on the Kaibab National Forest,” which can be viewed at https://youtu.be/IpFWb5NDyPI.

“I am hopeful this is a product that can be used to help educate, raise awareness, and highlight the collective efforts necessary to build a successful wildland fire management program,” Gonzales said. “On the Kaibab, we have been fortunate to have past and present employees at all levels of the organization who truly understand fire and who have helped build an extensive history of using wildland fire to achieve benefits to many resource areas across the forest, from protection of the wildland urban interface to ecosystem restoration to cultural and heritage site preservation and more. It is critical that this important work continue, and I hope the video will help spread the word about our efforts.”