Category Archives: National Government

Recall of Northstar Label Gabapentin Capsules

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ucm424493Dayton, NJ, Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.

Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules.

Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.

Aurobindo Pharma USA, Inc. is notifying its distributors and customers by recall letters and is arranging for return of all recalled product. Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase.

Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 or PVG@aurobindousa.com Monday through Friday, 8:30AM to 5:00PM EST. 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.

Great American Appetizers, Inc. Recalls Hyvee Mozzarella Cheese Sticks Due To Undeclared Soy Flour, Yellow #5, And Yellow #6

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640px-ucm423215Great American Appetizers, Inc. of Nampa, Idaho is recalling 662 cases of HyVee Mozzarella Cheese Sticks because they may contain undeclared soy flour, yellow #5 and yellow #6. People who have an allergy or sensitivity to soy, yellow #5 or yellow #6 can run the risk of serious allergic reaction if they consume this product.

The HyVee Mozzarella Sticks were distributed to retailers in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

The HyVee Mozzarella Cheese Sticks affected are in an 8 oz. (227 g) carton (UPC #075450149913). The product date codes are printed on the end of the carton: 14290402 (BEST IF USED BY 4/17/2016) and 14295402 (BEST IF USED BY 4/22/2016). No other date codes are affected by this recall.

No illnesses have been reported to date.

This incident was discovered in-house by the company’s internal packaging review. Great American Appetizers, Inc. staff determined that the new carton did not accurately describe all allergens present in the product during the packaging update.

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

Consumers who have purchased HyVee Mozzarella Cheese Sticks may return them to the place of purchase for a full refund. Consumers with questions may contact the company at: 1-800-282-4834 from 8AM – 5PM Mountain Time, or email inquiries to KalaT@appetizer.com.

B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product

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B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products.  There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.

This recall affects the following products:

Consumer UPC # Size Best By Date Range Description
0 39000 00805 1 10oz May 18, 2015 – Feb 10, 2016 Ortega Taco Dinner Kit
0 39000 00818 1 16.7oz May 18, 2015 – Feb 10, 2016 Ortega Taco Dinner Kit
0 39000 00820 4 1.25 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Seasoning
0 39000 00821 1 3.75 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Seasoning  (3 Pack)
0 39000 00860 0 5 lb. Feb 18, 2016 – Nov 3, 2016 Ortega Taco Meat Seasoning (Foodservice)
0 39000 00861 7 9 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Meat Seasoning (Foodservice)
0 39000 00890 7 8 oz Feb 18, 2017  –  Nov 10, 2017 Ortega Taco Sauce – Mild
0 39000 00891 4 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Hot
0 39000 01012 2 15.2oz May 18, 2015 – Feb 10, 2016 Ortega Soft Taco Dinner Kit
0 39000 01892 0 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Medium
0 39000 01893 7 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Mild
0 39000 01894 4 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Medium
0 41501 00806 5 9.15oz May 18, 2015 – Feb 10, 2016 Ortega Whole Grain Taco Kit
0 41501 00824 9 1.25oz Feb 18, 2016-Nov 3, 2016 Ortega 40% Less Sodium Taco Seasoning
0 41501 00832 4 5oz May 18, 2015 – Feb 10, 2016 Ortega “Tacos for Two” Kit
0 41501 00882 9 144 g 15 MA 18- 16 FE 10 Ortega “Tacos for Two” Kit (Canada)
0 41501 00897 3 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Green Taco Sauce – Mild
0 41501 00898 0 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Enchilada Sauce
0 41501 00907 9 16 oz Feb 18, 2017-Nov 10, 2017 Ortega Green Taco Sauce  –  Mild
0 41501 01014 3 13.6 oz May 18, 2015-Feb 10, 2016 Ortega Whole Wheat Soft Taco Kit
0 41501 01015 0 21.3oz May 18, 2015 – Feb 10, 2016 Ortega Grande Hard & Soft Taco Dinner Kit
0 41501 01058 7 15.9oz May 18, 2015-Feb 10, 2016 Ortega Whole Grain/Whole Wheat  Hard & Soft Taco Kit
0 41501 01895 8 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Hot
0 41501 08351 2 9.8oz May 18, 2015 – Feb 10, 2016 Ortega Fiesta Flats Kit
0 41501 79811 9 3.75 oz Feb 18, 2016-Nov 3, 2016 Las Palmas Taco Seasoning Packet (3 Pack)
0 41501 79812 6 106 g 16 FE 18 –  16 NO 03 Las Palmas Taco Seasoning Packets (3 Pack) (Canada)
0 41501 79890 4 8 oz Feb 18, 2017-Nov 10, 2017 Las Palmas Taco Sauce (Mild)
0 41501 79990 1 226g 17 FE 18 – 17 NO 10 Las Palmas Taco Sauce (Mild) (Canada)
N/A .33 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Sauce Packets (Foodservice)

The recalled products were distributed in retail stores and foodservice outlets nationwide.

This recall does not apply to any other sizes or varieties of Ortega Seasoning Mix or to any Ortega Seasoning Mixes in canisters, all of which are correctly labeled.  For example, this recall does not include Ortega Fajita Seasoning Mix, Ortega Fish Taco Seasoning Mix, Ortega Chili Seasoning Mix, Ortega Chipotle Seasoning Mix or Ortega Burrito Seasoning Mix, all of which are correctly labeled.  This recall also does not include any Las Palmas Enchilada Sauce, which is correctly labeled.

“The safety of our consumers is our number one priority.  We are committed to providing safe, quality products while observing the highest ethical standards in the conduct of our business,” said William Wright, Executive Vice President of Quality Assurance and R&D at B&G Foods.  “The core values that we’ve embodied since the company was founded in the 1800s — honesty, integrity and accountability — guide our actions as we take the appropriate measures to address this issue.”

This recall was initiated in consultation with the FDA after it was discovered that ingredients from a single supplier used in the affected products were contaminated with peanut and almond allergens. B&G Foods has since terminated its relationship with this supplier and is receiving these ingredients from other sources in anticipation of resuming production shortly.

Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund.  Consumers with questions may contact the company’s recall hotline at 877-929-2576 from 8:00 a.m. ET to 8:00 p.m. ET, or visit www.ortega.com for additional information.

Male Subject Found Deceased Near Jolly Sink, North Kaibab Forest

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coco-sheriff-300pxFREDONIA – On September 13, 2014 deputies of the Coconino County Sheriff’s Office Northern District received a report of a suspicious abandoned vehicle near the Jolly Sink area on the North Kaibab National Forest. A deputy from the Fredonia Substation responded and with the help of a local rancher located a deceased male subject at the bottom of a nearby cliff near the vehicle. The Sheriff’s Office Criminal Investigation Division responded to investigate the scene. The male subject was identified as a white male in his mid-fifties from out of state. Release of the identity of the male is pending notification of family members. The incident is currently under investigation by the Coconino County Sheriff’s Office as well as the Coconino County Medical Examiner’s Office.

North Kaibab Ranger District Personal-Use Fuelwood Cutting Season Ends Nov. 30

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FREDONIA – The North Kaibab Ranger District would like to remind residents that the 2014 Personal Use Fuelwood Cutting Season ends on November 30, 2014. All unused fuelwood cutting permits will not be valid afterward.

Permits are issued for dead and down (dead standing and downed trees) fuelwood cutting for all species. Permits are $5 per cord, with a four-cord minimum and 10-cord maximum purchase, and are available for purchase from 8 a.m. to 4:30 p.m. Monday through Friday at the North Kaibab Ranger District Office located at 430 S. Main St., Fredonia, AZ. 86022.

The district will resume the sale of wood cutting permits for the 2015 season in May 2015, pending appropriate weather conditions. Additional information on fuelwood permits is available by contacting the North Kaibab Ranger District office at (928) 643-7395.

Hawaii Firm Recalls Frozen Pork Products Due To Misbranding and Undeclared Allergen

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WASHINGTON – Kulana Foods Ltd., a Hilo, Hawaii establishment is recalling approximately 4,465 pounds of frozen, fully cooked pork products because of misbranding and an undeclared allergen. The products are formulated with a soy sauce that contains wheat, a known allergen, which is not declared on the label.

This is a Class II Recall which presents a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.

The products subject to recall include:

  • Various weight (approximately .75 – .90 lb.) packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case codes: 03414, 07214, 12814, 16914, 21114, 28114, 03713, 05113, 06513, 23313, or 34513.
  • 5-pound packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case code: 09214.

The products bear the establishment number “EST. 12445” inside the USDA mark of inspection on the label. The products were produced on various dates between Feb. 6, 2013 and Oct. 8, 2014 and shipped to retail locations and for foodservice use on the islands of Hawaii and Oahu.

The problem was discovered by FSIS personnel during a label review at the establishment. FSIS personnel are responsible for verifying that establishments are actively labeling the eight most common food allergens. Wheat was a sub-ingredient of soy sauce used in the product and was inadvertently left off the product label.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Marin Food Specialties, Inc. Initiates Voluntary Recall of Imported Organic Raw Almonds (Bitter Almonds)

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Due to Elevated Levels of Naturally Occurring Hydrogen Cyanide
raw-almonds
Marin Foods Specialties, Inc. of Byron, CA is voluntarily recalling Organic Raw Almonds (bitter almonds), due to them possibly containing elevated levels of naturally occurring hydrogen cyanide according to laboratory test results. To date, no human illnesses have been associated with these products and they have been pulled from sale.

Bitter almonds are the wild form of the edible “sweet almonds.” Bitter almonds contain a chemical called glycoside amygdalin, which becomes transformed into toxic prussic acid (hydrogen cyanide) after they are crushed or chewed. Eating foods that contain prussic acid may result in some or all of the following signs and clinical symptoms within minutes: dizziness, headache, nausea and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness. Exposure to higher quantities of food containing prussic acid may cause other more serious health effects including convulsions, loss of consciousness, low blood pressure, lung injury, slow heart rate, and respiratory failure leading to death. Showing these signs and symptoms does not necessarily mean that a person has been exposed to cyanide. Treatment with supportive measures and available specific and efficacious antidotes frequently allows survival.

The products were labeled as “Whole Foods Market Organic Raw Almonds Imported from Italy” and “Whole Foods Market Organic Raw Almonds Imported from Spain,” and were packaged in 13.5 oz. plastic tubs. The recalled products have sell-by dates from 4/18/15 to 6/7/15 and a UPC code of UPC 9-99482-00071-7. The recalled product was distributed to Whole Foods Market stores only in Northern California, Oregon, Washington, Reno, Nevada and Boise, Idaho.

Early opportunity to preview 4FRI final environmental impact statement and draft record of decision

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350-4friFLAGSTAFF – The Forest Service is providing the public with an early opportunity to preview the Final Environmental Impact Statement (FEIS) and draft Record of Decision (DROD) for Phase 1 of the Four Forest Restoration Initiative (4FRI).  The FEIS and DROD for the first analysis area on the Coconino and Kaibab National Forests will be available by November 21, 2014 at the 4FRI website.

In order to allow additional time for public consideration of these extensive documents, online access to the FEIS and DROD is being made available prior to the official start of the formal objection period.

“This environemntal analysis and the subsequent decision will help shape restoration action on almost a million acres for a decade,” said Kaibab National Forest Supervisor, Mike Williams. “An early preview will give the public extra time to review, understand, and ask questions about a significant step forward for our landscape.”

The FEIS analyzes about one million acres on the Coconino and Kaibab National Forests in northern Arizona. The Coconino and Kaibab National Forests are proposing 586,110 acres of restoration activities with approximately 355,708 acres on the Flagstaff, Mogollon, and Red Rock districts of the Coconino NF and 230,402 acres on the Williams and Tusayan districts of the Kaibab NF. The completed environmental analysis and a subsequent final ROD for Phase 1, provide the legal authority to accelerate restoration activities.

“The FEIS and DROD incorporate years of stakeholder and public input including key concerns such as the protection of large and old trees. Meaningful collaboration continues to be essential to our success on this project,” added Williams.

In accordance with federal regulations, the Forest Service will offer a 45-day formal objection period on the FEIS, which will begin with the publication of the Notice of Availability (NOA) in the Federal Register.  The NOA is expected to be published in early December 2014.

Injured hiker rescued from the Grand Canyon Monday

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640-GC-Rescue-01

Photos courtesy of the Coconino County Sheriff’s Department.

640-GC-Rescue-03GRAND CANYON – Elements from the Coconino County Sheriff’s Search and Rescue, Arizona DPS, Flagstaff Fire Department and National Park Service performed a dramatic rescue at the Grand Canyon in the early morning hours Monday. A 68-year-old Tuscon woman was injured when she fell from a trail while hiking.

The female hiker was hiking with two others along the Clear Creek Trail on Sunday, November 2 when about 7 p.m. she slipped and fell down a slope off of the trail. The hikers fall stopped with her head down slope and about three feet from a cliff’s edge that dropped down 80 feet to the creek bed below. When the hiker attempted to recover and move, she would slide further down slope due to very loose soil and rocks. The victim, fearing that she would slide over the cliff edge, lay still as her two friends activated a satellite emergency notification device or SPOT device.
640-GC-Rescue-02The National Park Service at the Grand Canyon’s South Rim was advised of the emergency notification and sent a ranger to area of the SPOT alert. The park service ranger hiked for six hours from Phantom Ranch, reaching the victim around 3:00 a.m. Rangers determined the victim had suffered some type of injury to her leg. Due to the dangerous and unstable ground, the Park Service requested assistance from the Coconino County Sheriff’s Office Search and Rescue Unit and the Arizona Department of Public Safety Air Rescue helicopter, who have the capability to conduct night operations.

The DPS helicopter flew two heli-rescue members, one from the Coconino County Sheriff’s Office and the other from the Flagstaff Fire Department into the canyon where they were able to land about a mile away from the victim. Rescuers hiked to the area where they had to secure ropes and rappel down to the victim. The victim was secured by a harness and then “short hauled” or flown out with a rescuer.

The victim was flown to the Grand Canyon Heli-base at the South Rim where she was transferred to a ground ambulance and taken to the Grand Canyon Clinic. She was treated for a fractured ankle and hypothermia and later released.

Bartlett Milling Company Issues Recall of Horse Food

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Bartlett Milling Company has initiated a limited recall of certain horse feeds due to potential Rumensin contamination. The products were distributed to customers and retailers in North Carolina, South Carolina, Tennessee and Virginia.

Rumensin contamination can result in health problems, including mortality, in horses. The products and lot number involved in the recall are:

  • 50 lb. bags of Bartlett Pasture Horse 10 Feed – Lot 288
  • 50 lb. bags of Cleveland Carolina Champion Horse Feed – Lot 288

The recalled products were packaged in typical brand-specific feed bags. Lot numbers are printed on the front and back of each bag.

Retailers have been contacted and instructed to immediately withdraw from sale the recalled product and to notify customers who purchased the product. Customers should discontinue feeding the product immediately. Customers who purchased this product should return remaining bags to their retailer.

For more information on the product recall, contact Bartlett Milling at 1-800-438-6016 from 8AM to 5PM Monday through Friday. Contact Bartlett at 1-336-655-1840 outside of regular business hours.

This recall is being conducted with the knowledge of the North Carolina Department of Agriculture & Consumer Services and the United States Food and Drug Administration.