Category Archives: National

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.

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.

Cory Gardner unseats Udall in Colorado

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300cory-gardnerCOLORADO – While you may have heard that the Republicans have taken the Senate, you may not have heard that one of the seats was taken in Colorado. In a surprising victory, Republican Cory Gardner of Colorado upset incumbent Democrat Mark Udall with almost 4% of the vote.

John Hickenlooper retained the office of governor by 1.36%

Doug Ducey declared the winner in the race for governor

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Arizona-electsPHOENIX – As of 8:44 Doug Ducey was declared the winner for the race for governor of the Great State of Arizona. Phoenix Mayor Greg Stanton blamed “the dark money” pouring into the State. He probably did not mind the nameless, faceless ads run against Ducey by Soros-funded organizations.

Ruben Gallego who beat out Mary Willcox in the primary, was the first race to be called in favor of the Democrat.

Generally across the board Republicans are doing well. In addition to the governors race, they may take the Secretary of State race with Michelle Reagan just over Terry Goddarad and the Office of Attorney General with Mark Brnovice over Democrat Felecia Rotollini.

Across the Federal offices most of the incumbents are winning. The rough race in District 9 looks like it will go to Kyrsten Sinema against Wendy Rogers. Currently it appears that Ann Kirkpatrick could take her race, but there are many precincts to report.

Tom Forese and Doug Little are running 7-percent over Democrat Sandra Kennedy.

The only blight on the night, so far, is Sylvia Allen is running behind Republican turned Independent so he could vote Democrat without the label Tom O’Halleran. Brenda Barton and Bob Thorpe are ahead by about 4-percent over Democrat challenger Lanny Morrison. This is with 38 of 89 districts reporting.

All of the elected State legislators will go in without a pay raise as Proposition 304 is being soundly defeated. Proposition 122 which would retain Tenth Amendment power in the Great State of Arizona is very close 50.67% to 49.33%. Terminally ill patients will likely have the opportunity to opt to take experimental drugs as Proposition 303 is being overwhelmingly approved 78.96% to 21.04%.

In Coconino, the sales tax referendum 403 is overwhelmingly passing.

These are based on unofficial results as the votes will have to be canvassed upon completion of the counting. Some of the races, such as the Secretary of State and Superintendent of Public Schools, currently led by Diane Douglas.

Congress does not authorize free cars for welfare recipients

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Fart-in-a-Smart-carA “news” report from Empire News from August of this year seems to be making the rounds and into some alternative web sites. The story concerns Congress approving free automobiles for welfare recipients along the lines of the fraud-plagued Obamaphone system.

The only problem is that Empire News is a satirical web site.

While it is probably the only thing they have not done, the fact remains that Congress has not authorized free motor vehicles to welfare recipients. The article and the accompanying e-mail scam are false. This administration is not friendly toward American citizens owning cars and guns. Or even having gasoline to operate the ones they own.

Even lamestream media would pick up an accomplishment such as this and twisted it into a “good” thing such as they did with the Unaffordable Health Care act.

In fact one “prominent” inappropriately named Arizona newspaper reported that health care rates are likely to go up this year. Due to “competition,” however, they are not likely to rise that much. The fact is that Obamadoesntcare has doubled, and even tripled in some cases, the premiums people have had to pay. It is actually the case of the blood and turnip analogy.

Here are some tips for those who might be taken in by satirical articles. Find the source of the original article. Web sites such as National Report and Empire News are the Internet equivalent of the political cartoon run by people who cannot draw. Check for a disclaimer. It might not be posted on their front page, but will be found in their about page or some where else on the web site.

The upside of this article is that we found a way to use the funny Smart car graphic circulating the Internet.

Texas Firm Recalls Boudin Products Due To Possible Temperature Abuse

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boudin

FSIS Photo


WASHINGTON – Carlton Foods, a New Braunfels, Texas establishment, is recalling approximately 25,764 pounds of fresh Boudin products, which were produced with pre-cooked rice that may have experienced temperature abuse and may contain an emetic toxin produced by Bacillus cereus, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The Boudin (sausage-like) products were produced on Aug. 22, 2014, through Oct. 17, 2014. The following products are subject to recall:

  • 12-oz. vacuum-packed packages of “RICHARD’S HICKORY SMOKED BOUDIN”
  • 12-oz. vacuum-packed packages of “RICHARD’S PREMIUM BOUDIN”
  • 12-oz. vacuum-packed packages of “RICHARD’S ‘HOT’ PREMIUM BOUDIN”
  • 16-oz. vacuum-packed packages of “RICHARD’S PREMIUM BOUDIN”
  • 32-oz. vacuum-packed packages of “RICHARD’S CAJUN GRILLERS BOUDIN”

The products subject to recall bear the establishment number “EST. 1943” or “EST. 961” inside the USDA mark of inspection. Products with the EST. 961 inside the mark of inspection would also have NB printed on the label. “Sell By” dates for the recalled products range from Oct. 28, 2014, to Dec. 16, 2014. The products were shipped to retail locations in Louisiana and Texas.

The problem was discovered by FSIS personnel during a Food Safety Assessment. During production, FSIS personnel observed pre-cooked rice, a component of the Boudin, being held at unsafe temperatures which could result in the products containing an emetic toxin produced by Bacillus cereus.

Bacillus cereus is a type of bacteria that can be found in a variety of foods, particularly rice that has been stored too long at room temperature. Emetic toxins produced by Bacillus cereus are characterized by nausea and vomiting occurring within 30 minutes to six hours after consumption of contaminated foods.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Individuals concerned about an illness should contact a health care provider.

Whole Foods Market Melrose Recalls Vegan Gingersnap Cookies Due to Mislabeling and Undeclared Allergens

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ucm420686Cambridge, MA – Whole Foods Market is recalling “Vegan Gingersnap Cookies” produced and sold only in the Melrose, Massachusetts location due to a labeling error that resulted in undeclared tree nut, milk, soy and egg allergens. The product has a “Sell By” date of October 28, 2014.

The six-packs of cookies labeled as “Vegan Gingersnap Cookies” contained tree nuts (walnut and almond), milk, soy and egg, known allergens, which are not declared on the label. People who have an allergy or severe sensitivity to those ingredients run the risk of serious or life-threatening allergic reaction if they consume these products.

The cookies were sold in the store between October 23 and October 26, 2014.

Signage is posted to notify customers of this recall, and all affected product has been removed from shelves.

No allergic reactions or illnesses have been reported.

Consumers who have purchased this product from Whole Foods Market Melrose may bring their receipt to the store for a full refund. Consumers with questions should contact their local store or call 617-492-5500 between the hours of 9am and 5pm EST.

Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes

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300-Baby-Wipes1

FDA Photo. Sample Only. See Table.

MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred’s, Kidgets, Member’s Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam’s Club, Family Dollar, Fred’s, and Diapers.com.

After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of a bacteria, called Burkholderia cepacia (B. cepacia), in some of these products. Soon after, on October 3, 2014 the company initiated a voluntary withdrawal of lots that had tested positive for the bacteria, as well as other baby wipes in the surrounding time frame. After some additional lots were tested, as a precautionary measure, Nutek believed it was a prudent decision to withdraw all its baby wipe products.

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.

As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.

The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility.

Nutek takes the safety of consumers and the quality of its products very seriously and is taking all appropriate steps to address the issue and ensure this does not happen again.

The company is working with the U.S. Food & Drug Administration and the affected retailers and distributors throughout this process to address the issue.
640-Baby-Wipes2

Brand Name Retailer Lot Numbers of Product Manufactured by Nutek
Cuties Internet and various retailers All Lots
Diapers.com Diapers.com All Lots
Femtex Family Dollar All Lots
Fred’s Fred’s All Lots
Kidgets Family Dollar All Lots
Member’s Mark Sam’s Club All Lots
Simply Right Sam’s Club All Lots
Sunny Smiles Walgreens All Lots
Tender Touch Various retailers All Lots
Well Beginnings* Walgreens Certain Lots±
*These lot numbers represent all lots manufactured by Nutek. There may be other lots that are made by manufacturers other than Nutek and that are not subject to this recall.