Perfection Bakeries, d/b/a/ Aunt Millie’s Issues Allergy Alert on Undeclared Sesame in “Our Family Hot Dog Buns 8 Ct.”

For Immediate Release

March 22, 2023

Contact Information

Aunt Millie’s
1-800-995-8245 Ext. 276

Company Announcement

Perfection Bakeries D/B/A Aunt Millie’s of Fort Wayne, IN. is recalling 8 ct. packages of Our Family® White Hot Dog Buns because they may contain undeclared sesame. People who have an allergy or severe sensitivity to sesame run the risk of serious or life- threatening allergic reaction if they consume these products.

The recalled “Our Family Hot Dog Buns 8 ct.” were distributed in retail stores in Michigan, Ohio, Indiana, and Illinois.

The product comes in a printed plastic package marked with “Our Family Hot Dog Buns 8 ct.” on the top and has a blue twist tie. The product UPC is 0-70253-75107-3, and include Best By Dates 4-9-2023 and earlier. One reaction has been reported to date in connection with this recall.

The recall was initiated after it was discovered the sesame-containing product was distributed in packaging that did not reveal the presence of sesame. Production of the product has been suspended until the FDA and Aunt Millie’s complete their investigation and are certain the market has been cleared of any incorrect packaging.

Consumers who have purchased "Our Family Hot Dog Buns 8 ct." are urged to return them to the place of purchase for a full refund. Any consumer who believes they are experiencing symptoms of an allergic reaction should seek immediate medical attention. Those with questions may contact Aunt Millie’s at 1-800-995-8245 Ext. 276 between 8 a.m. – 5 p.m. EST.

Second Nature Brands Issues Allergy Alert on Undeclared Wheat in Gluten Free Reese’s Pieces Brownie Brittle

For Immediate Release

March 23, 2023

Contact Information

Second Nature Brands
(800) 651-7263
recall@browniebrittle.com

Company Announcement

Second Nature Brands of Madison Heights, MI, is recalling its 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle because they may contain undeclared wheat.

People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Gluten Free Reese’s Pieces Brownie Brittle were distributed nationwide in retail stores and through online orders.

The product comes in a 4-ounce pouch UPC 711747011562 marked with lot codes SG 1054 15/NOV/2023 1S and SG 1054 15/NOV/2023 2S on the backside of pouch.

One illness has been reported to date in connection with this problem, to date.

The recall was initiated after it was discovered that the gluten-containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by cross-contamination at a co-manufacturer, resulting in undeclared wheat in the product.

Production of the product has been suspended until FDA and the company are certain that the problem has been corrected.

Consumers who have purchased 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle with lot codes SG 1054 15/NOV/2023 1S and SG 1054 15/NOV/2023 2S should not consume the product and should contact Brownie Brittle for a full refund.

Consumers may contact the company by calling at (800) 651-7263 Monday-Friday from 8:30AM - 5:00PM EST or via email at recall@browniebrittle.com Second Nature Brands is conducting this recall with the full knowledge and cooperation of the U.S. Food and Drug Administration.

Kelley Foods Recalls Smoked Baby Rope Sausage Product Due to Misbranding and an Undeclared Allergen

For Immediate Release

March 23, 2023

Contact Information

Kelley Foods
David Werner
817-759-6000

Company Announcement

WASHINGTON, March 23, 2023 – Kelley Foods, an Elba, Ala. establishment, is recalling approximately 1,455 pounds of smoked baby rope sausage due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains cheese, thereby milk, a known allergen, which is not declared on the product label.

The fully cooked smoked baby rope sausage item was produced on Jan. 10, 2023. The following product is subject to recall [view labels]:

• 12-oz. vacuum-packed packages containing “KELLEY Naturally Hardwood Smoked JALAPEÑO PEPPER BABY ROPE SAUSAGE” code 2705493011 and a use or freeze by date of May 11, 2023.

The product subject to recall bears establishment number “EST. 8016” inside the USDA mark of inspection. These items were shipped to retail locations in Alabama and Florida.

The problem was discovered when the firm notified FSIS that a grocery store manager found that the Kelley Foods Jalapeño Pepper Baby Rope Sausage appeared to contain cheddar cheese, which was not listed as an ingredient on the product label. Upon further investigation, the firm confirmed that its jalapeño and cheddar baby rope sausage product contained the wrong label.

There have been no confirmed reports of adverse reactions due to consumption of this product. Anyone concerned about an injury or illness should contact a healthcare provider. 

FSIS is concerned that some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers and members of the media with questions about the recall can contact David Werner, Senior Vice President of Independent Sales and Marketing, Kelley Foods, at 817-759-6000.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Mutual Trading Co., Inc Issues Allergy Alert for Undeclared Soy in Sauces

For Immediate Release

March 20, 2023

Contact Information

la.foodsafetygrp@mutual.us

Company Announcement

Mutual Trading Co., Inc. of El Monte, CA is recalling 60 fl oz of Kagome Worcester Sauce, 10 fl oz of Kagome Chuno sauce, and 8g of Kagome Take out Tonkatsu Sauce because the package labels contain undeclared soy allergen. People who have an allergy or severe sensitivity to soy allergen run the risk of serious or life-threatening allergic reaction if they consume these products.

The products were distributed in AZ, CA, HI, LV, MD, NY, TX, and Washington D.C. mainly through restaurants and some retail stores until 3/16/2023.

• The Worcester Sauce is in a 60 fl oz plastic bottle, UPC code is 7676451130, and lot code is 2024.5.26 or before this date.
• The Chuno Sauce is in a 10 fl oz plastic bottle, UPC code is 76764423003, and lot code is 2024.4.28 or before this date.
• The Take out Tonkatsu Sauce is in a 8g plastic bag, and UPC code is 072546242749, and lot code is 2023.7.29 or before this date.

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

The recall was initiated after it was discovered that the product containing soy was distributed in packaging that did not declare the presence of soy.

Subsequent investigation indicates the problem was caused by missing to indicate soy from a 2nd derived ingredient.

Mutual Trading Co., Inc immediately responded to this issue and has already taken action to stop sales and distribution of the affected products.

Consumers who have purchased the product are urged to return them to the place of purchase for a full refund.

Consumers with questions may contact the company at la.foodsafetygrp@mutual.us #20244 (LA/NY/Cherry) Kagome Worcester Sauce 6/60 fl oz.

The Food and Drug Administration (FDA) recently released a notice for allergen extracts used for food allergy testing. The warning is about severe allergic reactions, called anaphylaxis [anna-fih-LACK-sis], following negative skin prick tests for food allergies.

This is not new information about skin prick tests used to diagnose a food allergy.

Allergists often use skin prick tests to help diagnose food allergies, as well as allergies to other substances such as pollen, animals, and mold.

This new warning only confirms what allergy experts know. It is NOT a new warning for people concerned about being diagnosed with and managing food allergies.

What Does the Notice From the FDA Say?

On March 3, 2023, the FDA released a statement saying they are requiring changes to the prescribing information for food allergy extracts used in skin prick tests. The new safety warning notes that anaphylaxis has been reported following some negative skin tests. It continues to add that health care providers should consider a blood test or oral food challenge to confirm a negative skin test in some cases.

Why Did the FDA Issue This Warning?

This new recommendation from the FDA is based on peanut extracts from one company during a very specific time period. There is no evidence that this applies to peanut extracts from other companies or other time periods, or toward any other food allergen skin testing.

The FDA chose to apply a warning to all food allergy extracts used in skin testing based on these few instances.

What Do People Need to Know About Anaphylaxis and Skin Testing for Food Allergies?

Allergen extracts go through very strict quality control. Although this warning may seem unsettling, it shows that the system is working to ensure high-quality products. The maker (ALK-Abelló) of the peanut allergen extract mentioned above voluntarily recalled certain lots.

Here are some things to keep in mind in light of this news from the FDA:

• If your child is eating a food without any issues, you do not need to remove the food from their diet.
• If your child tested negative to a food on a skin prick test in the past, you do not need to worry about the accuracy of those results.
• A history of allergic reactions to a food outweighs allergy test results. For example, if your child has an allergic reaction every time they eat peanuts but they have a negative skin test for peanuts, they may have an allergy to peanuts. Your doctor may do additional testing to confirm diagnosis.
  
  

If your child has a history of symptoms when eating a certain food and has a negative result on a skin prick test, guidelines recommend that their allergist do more testing. Allergists can order serum IgE testing (a type of blood test) for that allergen or do a medically-supervised oral food challenge (which is the gold standard for diagnosing a food allergy) to help confirm the allergy.

False positives on food allergy tests are traditionally the bigger issue. They can lead to improper diagnosis of a food allergy. This can cause people to unnecessarily restrict their diet, lead to higher food and medical costs, and reduce quality of life. A positive test result for a food by itself does not necessarily confirm a food allergy. A doctor looks at a number of things before diagnosing a food allergy. Food allergy testing should not occur if there is no history of symptoms after eating a specific food.

The FDA has not yet addressed “at-home” allergy tests. These tests look for the wrong antibody. Many people are using them to self-diagnose food allergies based on incorrect information and interpretation of test results without considering medical history.

For these reasons, we recommend that you see a board-certified allergist if you think you or your child has a food allergy. An allergist should ask about full medical history and review the results of diagnostic tests when diagnosing food allergy.

Where Can I Learn More About Food Allergy Testing?

Read these resources to learn more about food allergy testing:

• More information about food allergy testing (This article explains why people may receive false positives or false negatives.)
• More information about oral food challenges
• Peanut Allergy Diagnosis: 2020 Practice Parameter Update from the Joint Task Force on Practice Parameters
  
  

Medical Review: Written with guidance from Matthew Greenhawt, MD; Michael Pistiner, MD, MMSc; and David Stukus, MD

BC Gourmet USA, Inc. Issues Allergy Alert on Undeclared Pine Nuts in Scarpetta Brand Pink Pesto

For Immediate Release

March 16, 2023

Contact Information

BC Gourmet USA, Inc.
781-959-7771 ext. 111

Company Announcement

BC Gourmet USA, Inc. of Lynn, Massachusetts is recalling 906 units of Scarpetta Brand Pink Pesto, because it contains undeclared pine nut allergen. People who have an allergy or severe sensitivity to tree nuts, run the risk of serious or life-threatening allergic reaction if they consume these products.

Scarpetta brand Pink Pesto was sold in small retail shops and grocery stores throughout Massachusetts and Bermuda. Scarpetta brand Pink Pesto was sold online throughout the USA.

The Scarpetta brand Pink Pesto is packed in a plastic container. The lot code is located on the bottom of the container.

The lot codes are NN149 expiring on 5/02/2023 and NN164 expiring on 12/09/2023 for a total of 906 units.

No illnesses have been reported to date.

The recall was initiated after the firm discovered that product containing tree nuts were distributed in packaging that did not reveal the presence of pine nuts. Subsequent investigation indicates the problem was caused by a document-control deviation.

Consumers who have purchased Scarpetta Pink Pesto are urged not to consume it, return to the place of purchase, or contact us at quality@saucesnlove.com or 781-959-7771 ext. 111 between 8:00am – 4:00pm, Monday - Friday to schedule a return and full refund.

Allergic diseases – like allergies, asthma, and eczema – are related. If your child has food allergies, they may also have other allergic diseases, including nasal allergies (allergic rhinitis) or allergic asthma. This is all thanks to the "allergic march" or “atopic march.”

About 19% of children in the U.S. have seasonal allergic rhinitis.^1,2 And most kids with asthma have allergic asthma. This type of asthma is triggered by allergens such as pollen, mold, dust mites, and cockroaches. If you have a child with food allergies, you’ll need to know about managing seasonal allergies.

The Asthma and Allergy Foundation of America (AAFA) has released the 2023 Allergy Capitals report. This report ranks the top 100 most challenging cities in the continental United States to live with seasonal pollen allergies.

The report looks at these important factors:

• Tree, grass, and weed pollen scores
• Over-the-counter allergy medicine use
• Availability of board-certified allergists/immunologists

This year, Wichita, Kansas, is the top Allergy Capital. This year’s report also highlights three topics related to seasonal pollen allergies:

• Self-care for seasonal allergies
• Climate change and worsening pollen seasons
• The importance of pollen sensors across the United States

“Managing pollen allergies is possible,” says Dr. Neeta Ogden, allergist and spokesperson for AAFA. “While it is best to avoid pollen allergy triggers, that may not always be possible, as this report makes clear. Working with a specialist can offer you solutions to improve your quality of life. It is important to consult with your allergist about your symptoms so you can devise a treatment plan that best helps you manage them. Allergy testing is also a way to better understand your allergy triggers and, therefore, better manage them.”

If your child has seasonal pollen allergy symptoms, talk with their allergist about testing and a treatment plan. Treating seasonal pollen allergies can help improve the quality of life for your child.

To see where your city ranks and for ways to manage seasonal pollen allergies, visit allergycapitals.com.

The 2023 Allergy Capitals report is an independent research project of AAFA and is made possible by a research support grant from the Consumer Healthcare Products Association.

Looking for candy for the kids, or kids at heart, in your life who have food allergies? Here is the Kids with Food Allergies (KFA) candy guide for food-allergy-friendly sweets! You can use this guide when shopping for candy for holidays, gatherings, treats, parties, or just for fun!

Avoiding Food Allergy Reactions

Remember, read labels every time on any food you give your child. Ingredients can vary for many reasons, especially on different sizes and treats in seasonal packaging.

Also, remember that a holiday, party, or celebration is not the best time to try new foods.

Find Allergy-Friendly Candy

Search KFA’s Allergy-Friendly Foods collection for candies and treats to fit many food allergy needs.

The buttons below take you to different searches for candy free of the allergens listed on the button. You can also set up your own custom search. Click “All Candy” then “Show Search Query.” Adjust the search for what you want to avoid and then click “Search” at the bottom of the form. The “Free of Top Food Allergens” button searches for candy and gum free of the most common food allergens – milk, egg, soy, peanut, tree nuts (not including coconut), sesame, wheat, gluten, fish, and shellfish.

     

Click the item in the search results to view the product listing in our Allergy-Friendly Foods collection. Each product includes information about allergens and ingredients, flavors, and varieties, as well as facility information from the manufacturers’ websites.

Some companies make holiday-themed candy. You can include seasonal tags in your search to find holiday candy. Here are the tags you can search for:

• Valentine
• Easter
• Halloween
• Thanksgiving
• Hanukkah or Chanukah
• Christmas
  
  

Note: The “Free of Top Food Allergens” and the “Peanut & Tree Nut Free” searches may include items that contain coconut.

KFA has also created a shareable handout for our candy guide. Our handout lists candies free of the top allergens. Download it to take shopping or to share with teachers and your child’s other caregivers.

Download, print, and share this guide

Below, we have listed a few of the products you can find in our Allergy-Friendly Foods collection.

Chocolate

Enjoy Life Chocolate Minis – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

free2b Chocolate Sunbutter Cups – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

PASCHA Chocolate Bars – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

No Whey! Foods Choco NoNo’s – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Gummies and Chewy Candy

Sunkist Fruit Gems – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, wheat, gluten, fish, and shellfish

Surf Sweets Delish Fish – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

YumEarth Organic Giggles – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Hard Candy and Lollipops

No Whey! Foods Chocolate Lollipops – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Spangler Saf-T Pops – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

YumEarth Organic Lollipops – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Mints and Gum

Glee Gum – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Red Bird Candy Puffs – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Seasonal

Amanda’s Own Chocolates – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, shellfish, mustard, sulfites, and lupin

No Whey! Foods Chocolate Lollipops – Free of milk, egg, soy, peanut, tree nuts (not including coconut), coconut, sesame, wheat, gluten, fish, and shellfish

Vermont Nut Free Solid Chocolates – Free of peanut, tree nuts (not including coconut), coconut, sesame, fish, and shellfish

Chocolate Emporium – Free of milk, egg, wheat, gluten, fish, and shellfish

Other Ways to Buy Allergy-Friendly Candy

In addition to our Allergy-Friendly Foods collection, you can also find many options online at the Natural Candy Store. Their site allows you to filter and shop by allergens too.

Originally published March 2017. Updated March 2023.

FSIS Issues Public Health Alert for Trader Joe’s Chicken Salad Due to Misbranding and an Undeclared Allergen

For Immediate Release

March 4, 2023

Contact Information

GH Foods NW, LLC
Angie Bouzerand, Director of Communications
(281) 610-1441
angie.bouzerand@calavo.com

Company Announcement

WASHINGTON, March 10, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that fully cooked, ready-to-eat (RTE) chicken salad product may contain cashews a known allergen, which is not declared on the product label. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

The fully cooked, RTE chicken salad products were produced on March 4, 2023. The following products subject to the public health alert are [view label]:

• 12-oz. clear plastic trays containing “TRADER JOE’S Wine Country WHITE CHICKEN SALAD WITH Cranberries & Pecans.” with a best by date of 3/12/2023.

The products subject to the public health alert bear establishment number “P-34834” inside the USDA mark of inspection. The product was shipped to retail locations in Idaho, Oregon, and Washington.

The problem was discovered when the firm notified FSIS that it received a consumer complaint that cashews were found in the chicken salad product.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

FSIS is concerned that some product may be in consumers’ refrigerators. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Consumers with questions regarding the public health alert can contact Taylor Farms at Customercare@taylorfarms.com or 855-455-0098. Media with questions regarding the public health alert can contact Taylor Farms at press@taylorfarms.com.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Nutrition is an important part of your child’s health. But if your child has food allergies – especially multiple food allergies – you may need to pay special attention to how they get their nutrients.

A registered dietitian nutritionist (RDN) who is familiar with food allergies may be able to help you create a balanced diet plan for your child.

If you think your child isn’t getting the nutrition they need after being diagnosed with food allergies, meeting with an RDN may be the next step. Kids with Food Allergies (KFA) has a resource with more information on finding, choosing, and working with an RDN.

Visit our webpage on how an RDN can help with food allergy management. We cover:

• The difference between an RDN and a nutritionist
• How an RDN will help you with your child’s nutrition
• How to find an RDN
• How to choose an RDN who specializes in food allergies
  
  

GH Foods NW, LLC Recalls Ready-to-Eat Salad with Chicken Products Due to Misbranding and Undeclared Allergens

For Immediate Release

March 4, 2023

Contact Information

GH Foods NW, LLC
Angie Bouzerand, Director of Communications
(281) 610-1441
angie.bouzerand@calavo.com

Company Announcement

WASHINGTON, March 4, 2023 – GH Foods NW, LLC, a Clackamas, Ore. establishment, is recalling approximately 106 pounds of ready-to-eat salad with chicken products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat, a known allergen, which is not declared on the product label.

The ready-to-eat lemon chicken & arugula salad products were produced February 28, 2023. The products are labeled with the correct top label but an incorrect bottom label. The incorrect bottom label contains the ingredient statement for a Broccoli Slaw and Kale Salad with White Chicken Meat product, which does not contain wheat. The following products are subject to recall [view labels]:

• 9.2 oz. plastic clamshell packages containing “TRADER JOE’S LEMON CHICKEN & ARUGULA SALAD” with “BEST BY 03/06/23” and lot code GHNW 059-06.

The products subject to recall bear establishment number “P-46987” inside the USDA mark of inspection. These items were shipped to Trader Joe’s locations in Idaho, Oregon, and Washington.                           

The problem was discovered when the producing establishment notified FSIS that the product had the incorrect ingredient statement label on the bottom of the package.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. 

FSIS is concerned that some product may be in consumers’ refrigerators. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers with questions about the recall can contact GH Foods NW, LLC Customer Service at (888) 449-9388. Members of the media with questions about the recall can contact Angie Bouzerand, Director of Communications, GH Foods NW, LLC at (281) 610-1441 or angie.bouzerand@calavo.com.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Kids with Food Allergies (KFA) is sharing this press release from Bryn Pharma to bring you the latest research news.

[PRESS RELEASE]

Bryn Pharma’s UTULY™ 13.2mg Intranasal Epinephrine Spray Provides Higher and More Sustained PK Compared to Standard Reference Product, the 0.3mg Epinephrine Autoinjector and Inpatient Standard of Care, the 0.5mg Manual Injection

Late-Breaker Pivotal Data Presented at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting

RALEIGH, N.C. – Bryn Pharma LLC, a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, today announced positive pharmacokinetic/pharmacodynamic (PK/PD) and safety data for its investigational 13.2mg intranasal (IN) epinephrine spray, UTULY™. The pivotal trial results were presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in San Antonio, Tex. The poster can be found here.

UTULY is an investigational self-administered form of epinephrine being studied for the treatment of type 1 allergic reactions, including anaphylaxis.

Key data points include:

• UTULY 13.2mg administered to opposite and same nostrils showed rapid absorption comparable to the 0.3mg autoinjector and resulted in higher and more sustained therapeutic epinephrine plasma levels compared to the 0.3mg epinephrine IM autoinjector.
• The number and percentage of subjects reaching therapeutic plasma levels of epinephrine in the acute period post-dose with UTULY were comparable to or higher than seen with the 0.3mg IM autoinjector which is the outpatient standard of care, accounting for over 95% of prescriptions.
• When compared to the inpatient standard of care (0.5mg IM manual syringe), the study results showed that UTULY had a faster rate of absorption and a higher or comparable acute and overall exposure.
• These results demonstrate that UTULY provides an enhanced PK profile (higher and more sustained) compared to the standard reference product, the 0.3mg epinephrine autoinjector.
• These data support the ability of UTULY 13.2mg to achieve therapeutic levels of epinephrine rapidly and to maintain those levels essentially twice as long as those achieved using the 0.3mg IM autoinjector with a similar safety profile to IM epinephrine.
• There were no deaths, serious adverse events (SAEs), or laboratory-related events reported in this study. Overall, the safety results for UTULY and IM administration routes were comparable, demonstrating that UTULY was safe and well tolerated.
  
  

“We were extremely pleased with the results achieved in this pivotal study, demonstrating that therapeutic levels of epinephrine were achieved as quickly and maintained those levels for essentially twice as long as those achieved using the current standard of care, 0.3mg IM autoinjector, with a similar safety profile,” said David Dworaczyk, Ph.D., CEO of Bryn Pharma. “The rapid attainment and sustained level of therapeutic levels of epinephrine are critical to optimize the successful treatment of anaphylaxis. This is an exciting advance for UTULY, and especially for the patient community that lives with severe food allergies and are seeking a needle-free alternative to autoinjectors.”

Anaphylaxis is a serious and sometime life-threatening acute allergic reaction that requires immediate attention. IM autoinjector epinephrine (EpiPen) is the first-line therapy for anaphylaxis in an outpatient setting. Patient use of autoinjectors is suboptimal due to not carrying their devices routinely, reluctance to use a self-injector due to needle anxiety or fear, or application error, along with the additional risk of injection injuries. There is a clear need for a needle-free, compact alternative for patients, without sacrificing the need to quickly reach and maintain therapeutic levels of epinephrine.

“When it comes to treating anaphylaxis, time is of the essence. Delayed epinephrine administration or suboptimal exposure during anaphylactic events may increase the risk of hospitalizations and potentially fatal outcomes. There should be no hesitation in terms of treatment with rapid uptake,” said Dworaczyk.

About the Study

This pivotal study was conducted to confirm the results observed in the dose-ranging study by comparing the pharmacokinetics (PK) of a single 13.2mg dose of UTULY to that of IM-administered epinephrine via autoinjector (0.3mg) the primary reference product, and prefilled manual syringe (0.5mg) as an additional point of reference. The study was designed to fully assess the comparability of the PK profiles of UTULY and the IM dosage forms as well as to assess the relative PD, safety and tolerability of IN epinephrine compared to epinephrine administered via an autoinjector in healthy adults.

Study results demonstrate that UTULY provides an enhanced PK profile (higher and more sustained) compared to the standard reference product, the 0.3mg epinephrine autoinjector.

Overall, the safety results for UTULY and IM administration routes were comparable, demonstrating that UTULY was well tolerated and that there were no new safety signals for the IN route of administration. There were no deaths, SAEs, or laboratory related events reported in this study.

About Bryn Pharma

Bryn Pharma, established in 2017, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine autoinjectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. For more information visit www.brynpharma.com.

Contacts

Rebecca Novak Tibbitt
Rebecca@RNTCommunications.com

Russell Stover Chocolates Issues Allergy Alert on Undeclared Pecan in Sugar Free Peanut Butter Cups

For Immediate Release

February 28, 2023

Contact Information

1-800-477-8683
consumerservices@russellstover.com

Company Announcement

Russell Stover Chocolates of Kansas City, Missouri, is voluntarily recalling two (2) Best Before Dates of its Sugar Free Peanut Butter Cups in 2.4 oz packaging due to the potential for undeclared pecans. The recalled Sugar Free Peanut Butter Cups may contain Sugar Free Pecan Delights. Pecans are not declared on the label. People who have an allergy or severe sensitivity to pecans run the risk a serious or life-threatening allergic reaction if they consume these products.

The recalled Sugar Free Peanut Butter Cups were distributed nationwide to wholesale and retail stores.

The recalled Sugar Free Peanut Butter Cups are packaged in a 2.4 oz plastic bag, and they are labeled with Best Before dates of 01MAY23 and 01JUN23 and UPC of 077260096937 with Lot code(s): K0521, K0321, K0421, L2122, L2221, L2321. The lot code and best before date can be found on the back of the product packaging, below the UPC.

The recall was initiated following consumer contacts regarding the wrong product inside the outer packaging for Sugar Free Peanut Butter Cups product.  Russell Stover has received no reports of any illness or allergic reactions related to this issue to date.

An error by the firm’s 3rd party co-packing company resulted in individually-wrapped Sugar Free Pecan Delight products being placed in the outer packaging for Sugar Free Peanut Butter Cups. The inner packaging correctly identifies the products as Sugar Free Pecan Delights and the physical Sugar Free Pecan Delight product appears distinct from the Sugar Free Peanut Butter Cup product.

Consumers who may have purchased this product may contact Russell Stover Chocolates directly for a voucher or replacement product. If you have any questions, please contact Russell Stover Chocolates on our website using the Contact Us Form at https://www.russellstover.com/contact-usExternal Link Disclaimer, or by email at consumerservices@russellstover.com or at 1-800-477-8683 operating hours Monday – Friday 8AM-5PM CST.

Lemonland Food Corp Issues Allergy Alert On Undeclared Soy, Wheat, Sesame, Peanut, Walnut, Milk, Crab, Shrimp, Fish (Anchovy, Big Eye Herring, Golden Threadfin Bream, Hairtail, Lizard Fish, Sardine, Pollock) In Multiple Products

For Immediate Release

February 28, 2023

Contact Information

206-771-7222

Company Announcement

Lemonland Food Corp of Kent, Washington initiated a recall of seasoned fisheries and seasoned vegetable products because it may contain undeclared soy, wheat, sesame, peanut, walnut, milk, crab, shrimp, and fish. People who have an allergy or severe sensitivity to those allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

Please see the attached list of the recalled products.

The firm distributed un-labeled plastic containers in 6oz, 8oz, 12oz, and 16 oz to H-mart, G-mart and M2M retail stores in Washington between 2/16/23 and 2/23/23. Those containers were labeled with H-mart, G-mart or M2M white adhesive labels and the allergens may have not been declared properly. Consumers could have purchased these affected products from stores between 2/16/23 and 2/23/23.

No illnesses or deaths have been reported to date.

The allergens mis-labeling issue was discovered during the inspection by the Washington State Department of Agriculture (WSDA) on February 22, 2023. The firm has stopped producing, re-packing, and distributing since February 23, 2023, and will resume operation when the new labels are available.

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

Customers with an allergy to any allergens mentioned above and have purchased the affected product at H-mart or G-mart stores are urged not to consume the product and dispose of it or return it to their place of purchase for a full refund.

Consumers with questions may contact the company at 206-771-7222, from 9am-4pm PST, Monday-Friday.

Sunny Dell Foods, LLC Issues Allergy Alert on Undeclared Tree Nuts (Pine Nuts) in "Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms"

For Immediate Release

February 21, 2023

Contact Information

Sunny Dell Foods, LLC
1-610-932-5164 Ext # 102

Company Announcement

Sunny Dell Foods, LLC. of Oxford, PA, is recalling its 12-ounce jars of "Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms" because the affected jars of the condiment may contain undeclared Trees Nuts (Pine Nuts). People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled "Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms" were distributed across retail stores in the Northeast U.S. and through mail order e-commerce.

The product comes in a 12-ounce, glass jar marked with lot # SD21160-03 RPOA, on top of the lid/cap, with UPC 7 47479 00110 6. This recall does not apply to other condiments with different lot numbers, or sauces & soups under the Rao’s Homemade brand. Only this lot is affected.

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

The recall was initiated after it was discovered that a tree nut-containing condiment product was distributed in the Rao’s Homemade Brand Roasted Peppers with Portobello Mushrooms packaging that did not reveal the presence of tree nuts (pine nuts). Subsequent investigation indicates the problem was caused by an accidental mislabeling during the production run.

Consumers who have purchased 12-ounce packages of "Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms" condiment are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-610-932-5164 Ext # 102, Monday to Friday, 9:00 a.m. to 5:00 p.m. Eastern Time.

Chukar Cherry Company of Prosser, WA is Voluntarily Recalling a Limited Quantity of Cherry Bombs Because the Product May Contain Hazelnuts

For Immediate Release

February 21, 2023

Contact Information

Chukar Cherries Customer Service
(800) 624-9544
customerservice@chukar.com

Company Announcement

FOR IMMEDIATE RELEASE – [02/20/2023] Chukar Cherry Company of Prosser, WA is voluntarily recalling a limited quantity of Cherry Bombs because the product may contain hazelnuts, an ingredient not identified on the packaging. People who have an allergy or severe sensitivity to hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume this product.

This recall is limited to the product and best by dates listed in the table below and were sold exclusively in Chukar Cherry Company stores in Prosser and Seattle, WA.:

• SKU - 21508
• Cherry Bombs 12oz
• “Best By” Dates - 
  • 07-2023
  • 08-2023
  • 09-2023
  • 10-2023
  • 12-2023
  • 01-2024
  • 02-2024

No other Chukar Cherry Company products are part of this recall. No allergic reactions have been reported to date.

Customers who may have purchased the above product prior to 2/10/2023 are urged to destroy or return them to the place of purchase if sensitive to hazelnuts.

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

Renowned for freshly made, locally grown cherry and nut confections—Chukar Cherry Company has placed customer service and consumer safety at the forefront for over 35 years. Customers can contact Chukar Cherries customer service at (800) 624-9544 with questions.

FSIS Issues Public Health Alert for New Seasons Pizza Sauce Due to Misbranding and Undeclared Allergens

For Immediate Release

February 23, 2023

Contact Information

Executive Vice President/Founder of Heritage Specialty Foods, LLC
Lana Slezak
503-252-1545

Company Announcement