Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll

For Immediate Release

January 26, 2023

Contact Information

(253) 507-5259
joybakeryllc@outlook.com

Company Announcement

January 26, 2023, Joy Joy’s Bakery Lakewood, Washington is recalling Ube Spanish Bread, Ube Ensaymada, and Ube Roll because it 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 this product.

The recalled Ube Spanish Bread, Ube Ensaymada, and Ube Roll are sold at Joy Joy’s Bakery in Lakewood, Washington and sold at Fubonn Supermarket in Oregon.

The recalled products are packaged in plastic bags or in plastic clear clamshell containers and labeled with Joy Joy’s Bakery sticker. There are no lot codes on packages and products were distributed between 1/15/23 and 1/25/23.

No illnesses have been reported to date.

The recalled products labels declared flour but it does not specify wheat flour. This labeling problem came to our attention by from the Oregon Department of Agriculture through the U. S. Food and Drug Administration.

Customers with a wheat allergy or sensitivity who have purchased the affected product 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 (253) 507-5259 or email joybakeryllc@outlook.com Monday-Wednesday from 7am-4pm, Thursday 7am-2pm, Friday 7am-4pm.

Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging

For Immediate Release

January 25, 2023

Contact Information

Snack Innovations, Inc.
1-888-445-5122

Company Announcement

Snack Innovations Inc. of Piscataway, NJ is issuing a voluntary recall on several batches of Drizzilicious branded mini rice cake bites, and drizzled popcorn products with the lot numbers listed below due to an undeclared peanut residue. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

The Drizzilicious products listed below were distributed nationwide through retail stores, and online ecommerce sites like Amazon.

Product size

Flavor Lot Code

Best by

UPC

• Drizzilicious mini rice cake bites 4oz and/or .74oz Bags - Birthday Cake
  • Lot/Best By: N3-11BHNV3552 / 21SEP2023
  • UPC: 4oz - 857900005402 ; .74oz - 857900005419
  • Lot/Best By: N3-11BHNV3462 / 12SEP2023
  • Lot/Best By: N3-21BHNV0093 / 09OCT2023
• Drizzilicious drizzled Popcorn 3.6oz Bags Birthday Cake Popcorn
  • Lot/Best By: N3-11BHNV3322 / 28JUL2023
  • UPC: 857900005525
• Drizzilicious mini rice cake bites 4oz and/or .74oz Bags Cinnamon Swirl
  • Lot/Best By:N3-11BHNV3562 / 22SEP2023
  • UPC: 4oz - 857900005167 ; .74oz - 857900005181
  • Lot/Best By: N4-11BHNV0163 / 16OCT2023
  • Lot/Best By: N3-11BHNV0053 / 05OCT2023
• Drizzilicious mini rice cake bites 4oz and/or .74oz Bags Cookies & Cream
  • Lot/Best By: N4-11BHNV0183 / 18OCT2023
  • UPC: 4oz -857900005167 ; .74oz - 857900005181
  • Lot/Best By: N3-11BHNV0093 / 09OCT2023
• Drizzilicious mini rice cake bites 4oz and/or .74oz Bags Salted Caramel
  • Lot/Best By:N3-11BHNV0083 / 08OCT2023
  • UPC: 4oz - 857900005167 ; .74oz - 857900005181
• Drizzilicious mini rice cakes 32-ct Variety box Variety (3-Flavors)
  • Lot/Best By: N4-11BHNV3562 / 9/22/2023
  • UPC: 853762002993
  • Lot/Best By: N4-21BHNV3532 / 9/19/2023

The products are packaged in Drizzilicious branded pillow bags and/or stand-up zip pouches and must have one of the lot codes listed above printed on the back of the bag.

No illnesses have been reported to date.

This voluntary recall was initiated as of the result of a recall that was initiated by one of our ingredient suppliers. Our supplier notified us that they discovered undeclared peanut residue in one of the sub-ingredients used in the process of making our products.

Consumers who have a peanut allergy should not eat any remaining product and are advised to return the product to the place of purchase for a full refund. If you are not allergic to Peanuts the products are safe for consumption.

Consumers with questions may contact the company at 1-888-445-5122 or visit our website at https://www.drizzilicious.com/recall/food-safety

On Dec. 4, New York Giants defensive back Dane Belton will wear special cleats during the team’s game against the Washington Commanders to help raise awareness for food allergies. He is participating in the NFL’s My Cause My Cleats campaign.

Food allergies have been very prominent throughout Dane’s life. He is allergic to milk, eggs, tree nuts, peanuts, shellfish, sesame, and coconut.

After his diagnosis, his mom looked to Kids with Food Allergies (KFA) for allergy-friendly recipes. So, Dane shared that selecting KFA for the My Cause My Cleats campaign was an easy choice. KFA is the food allergy division of the Asthma and Allergy Foundation of America (AAFA).

“I’m thankful for you guys helping me and my mom out,” shared Dane. “I wanted to give back and spread the knowledge you provide.”

He also shared, “It's especially important for me because not a lot of people understand the hardship of having a lot of food allergies. I wish more people understood that for us it’s challenging everywhere we go. [We have] to always be verbal about what we have. I feel like it's getting better now, but a lot of restaurants still don’t have allergen menus. You have to talk to a chef one on one and see what you can eat.”

During week 13 of the NFL season, players wear their causes on their feet. They wear custom-designed cleats that represent charities they are passionate about. The cleats will then be auctioned off to raise money for the chosen organizations. To learn more, visit nfl.com/mycausemycleats.

Dane’s cleats will feature the KFA and AAFA logos To check out his cleats, tune into the New York Giants game against the Washington Commanders on Dec. 4 at 1 p.m. ET.

Dane recalls growing up with food allergies being “very stressful on my mom … She was super adamant about making sure everyone knew about my allergies.” This included his day care, school, after-school activities, sports teams, and more.

His mom used some KFA resources to help manage his food allergies, including some of KFA’s Safe Eats® recipes.

“I know she got a lot of dessert recipes [from KFA] for sure,” recounted Dane. “[Desserts were] the most challenging being allergic to dairy and eggs. A lot of desserts use those.”

He shared memories of how his mom would try out new recipes and how excited he was when he was able to eat new foods. The recipes from KFA were especially helpful in adding variety to his diet.

When asked if he had a favorite KFA recipe he shared, “I remember I was 12 and I’d never had pumpkin pie and she made it … it was the first time I’d ever had it.” He loved it!

Growing up with food allergies can be challenging. And even today, food allergies still affect Dane.

“Being a professional athlete we are tasked with taking in a lot of protein to keep up with our daily regimen and workouts. A lot of people drink whey protein drinks and I’m allergic to that,” shared Dane. He has to get creative and find different ways to get protein.

Dane has also learned that having a solid support system makes it a lot easier to manage food allergies. This includes the New York Giants staff. For example, when traveling they ensure he has safe food to eat so he can focus on playing football.

Now the NFL’s My Cause My Cleats campaign is giving Dane an opportunity to help other people learn about food allergies.

When asked about what advice he has for other people with food allergies, Dane shared, “Don’t be afraid to ask questions! You may learn there is more that you can eat.”

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

For Immediate Release

January 23, 2023

Contact Information

SkinnyDipped®
1-866-957-9907
hello@skinnydipped.com

Company Announcement

January 20, 2023, SkinnyDipped® of Seattle, WA is voluntarily recalling a limited quantity of SkinnyDipped® Dark Chocolate Cocoa Almond 3.5oz and SkinnyDipped® Dark Chocolate Salted Caramel Cashew 3.5oz due to an undeclared peanut allergen in an ingredient from a raw material supplier. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reactions if they consume these products. The recalled products do not declare peanuts in the ingredient statement or as a disclosed allergen.

This recall is limited exclusively to the products and Best By Dates listed in the table below and were sold in retail stores nationwide from January 8, 2023 to January 20, 2023:

• SkinnyDipped Dark Chocolate Salted Caramel Cashews 3.5oz
  • UPC: 8-51562-00841-2
  • B23005 - 05/05/2024
  • B13006 - 05/06/2024
• SkinnyDipped Dark Chocolate Cocoa Almonds 3.5oz 
  • UPC: 8-61297-00030-8
  • B22354 - 04/20/24
  • B12355 - 04/21/24
  • B22355 - 04/21/24
  • B12354 - 04/20/24

The lot code and best buy information can be found on the back of the package in the lower right corner as shown in the following images:

No other SkinnyDipped® products are part of this recall. No allergic reactions have been reported to date.

Consumers who have the recalled product should not eat it, should discard any product, and should keep any packaging to return to the retailer where it was purchased for a replacement or refund. If you have any questions, please reach out to SkinnyDipped® at 1-866-957-9907 (M – F, 9am – 5pm PT) or hello@skinnydipped.com or for more information visit www.skinnydipped.com/pages/recallExternal Link Disclaimer.

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

The quality, safety and integrity of our products remain the number one priority of SkinnyDipped®. We sincerely apologize for any inconvenience to both our consumers and retail customers.

The FASTER Act of 2021 made sesame the 9th major allergen in the U.S. and required food manufacturers to label sesame like the other 8 major allergens beginning in 2023. This was a long-fought victory that began for the Asthma and Allergy Foundation of America (AAFA) and our Kids with Food Allergies division back in 2008.

We are concerned and disappointed over reports of food companies intentionally adding sesame flour to products as a way to comply with required sesame allergen labeling. This practice ignores the purpose of the FASTER Act and is shameful way to avoid setting up food allergy-safe manufacturing processes that reduce cross-contact risk. (Cross-contact occurs when a food allergen comes in contact with food or an item not intended to contain that allergen.)

We do not have a full list of manufacturers who are adding sesame to their products and there may be regional differences. We have heard reports of Chick-fil-A, Olive Garden, Wendy’s, Pan-o-Gold, Thomas’ Breads, but it is very important to continue to read labels and ask restaurants. Some foods that were safe before may now contain sesame allergen. Be especially careful when reviewing baked good products.

We are working with industry representatives to identify bakers and restaurants who are taking the appropriate steps to ensure the safety of the food allergy community and look forward to sharing those brands as well.

With improved, regulated, and evidence-based precautionary allergen labeling, AAFA believes we can both improve safety for consumers with food allergies and reduce liability concerns for industry. We are eager to work with industry, Congress, the Food and Drug Administration (FDA), and our food allergy allies to enact solutions that prevent potentially harmful manufacturing practices now and in the future.

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

[PRESS RELEASE]

FDA accepts nirsevimab application as first protective option against RSV disease for all infants

FDA accepts nirsevimab application as first protective option against RSV disease for all infants

• Nirsevimab would be the first broadly protective option against RSV disease designed for all infants, if approved
• Nirsevimab delivered consistent protection of approximately 80% against medically attended RSV disease across several trials in healthy term and preterm infants and has been approved under accelerated review in the EU and the UK

Paris, January 5, 2023. The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab is being developed jointly by Sanofi and AstraZeneca and, if approved, would be the first protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. The FDA has indicated they will work to expedite their review. The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023.

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“This is a landmark file acceptance in the US as it brings us one step closer to offering the first and only broadly protective option against RSV disease designed for all infants. Given the unprecedented number of otherwise healthy infants who have been hospitalized with RSV this year in the US and the recurrent pattern of RSV epidemics year after year, it is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the healthcare system.”

RSV is a very contagious virus that can lead to serious respiratory illness, according to the Centers for Disease Control and Prevention (CDC).10 In the US, RSV is the leading cause of hospitalisation for babies under one.11 Any infant can be hospitalized in their first RSV season: about 75% of infants hospitalized for RSV in the U.S. are born at term, with no underlying conditions.^12-14 The current 2022/23 RSV season has placed a particularly high burden on infants and families in the United Stated with the American Academy of Pediatrics (AAP) requesting the White House declare an emergency to support the national response to the alarming surge of pediatric hospitalizations due to RSV and influenza.

Dr William Muller
Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois
"A substantial burden of disease from RSV affects infants, families, and healthcare providers every year. Effective interventions to prevent RSV are a critical need. This year in the US, we’ve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the healthcare system, highlighting the urgency of addressing this problem."

The submission was based on results from the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials.^1-8 Results across the MELODY and Phase 2b trials showed that nirsevimab demonstrated consistent protection of approximately 80%, against medically attended RSV disease with a single dose.^1-5

In these trials, nirsevimab helped protect an all-infant population (including healthy term, late preterm, and preterm infants, as well as infants with specific health conditions) against RSV disease requiring medical care, including physician office, urgent care, emergency room visits and hospitalizations, through the duration of the RSV season.1-8 The safety profile of nirsevimab was similar to placebo. Nirsevimab also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.^7-9

About nirsevimab

In the U.S., nirsevimab is an investigational single-dose long-acting antibody designed to help protect all infants from birth through their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract infection (LRTI) caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.¹⁵

In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits.

Nirsevimab has been granted designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by the China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the FDA; access granted to the European Medicines Agency (EMA) PRIority MEdicines scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). Nirsevimab was approved by the European Commission in October 2022, and by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in November 2022.^16,17

About the clinical trials

The Phase 2b trial was a randomized, placebo-controlled trial designed to measure the efficacy of nirsevimab against medically attended LRTI through 150 days post-dose. Healthy preterm infants of 29–<35 weeks’ gestation (n= 1,453) were randomized (2:1) to receive a single 50mg intramuscular injection of nirsevimab (n= 969) or placebo (n= 484) at the RSV season start.^3,4 The primary endpoint was met, significantly reducing the incidence of medically attended LRTI caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo.^3,4 The proposed dosing regimen was recommended based on further exploration of the Phase 2b data.³ When considering the dosing regimen recommended for approval in this study, nirsevimab reduced the incidence of medically attended LRTI caused by RSV by 86.2% (95% CI: 68.0, 94.0) in gestational age ≥29 to <35 weeks.^3,4 The subsequent Phase 3 study, MELODY, applied the recommended dosing regimen.^1,2

The Phase 3 MELODY (primary cohort) trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of nirsevimab against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.^1,2 The primary endpoint was met, significantly reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV compared to placebo.^1,2 Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of nirsevimab or placebo.^1,2

Following the analysis of the initial 1,490 infants within the MELODY primary cohort additional infants continued to be enrolled. A total of 3,012 healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season were randomized to receive nirsevimab (n=2,009) or placebo (n=1,003). In the exploratory analysis, a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of nirsevimab reduced the incidence of medically attended LRTI caused by RSV through 150 days after dosing by 76.4% (95%: CI 62.3, 85.2) compared to placebo, with an acceptable safety profile. Further, nirsevimab demonstrated a 76.8% (95%: CI 49.4, 89.4) reduction in the risk of RSV LRTI with hospitalization through 150 days after dosing compared to placebo.

MEDLEY was a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for nirsevimab in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive palivizumab.^7,8 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were randomized to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of nirsevimab or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose.7,8 Serum levels of nirsevimab following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.⁷

The safety profile of nirsevimab was similar to palivizumab in the MEDLEY Phase 2/3 and consistent with the safety profile in term and preterm infants studied in the MELODY Phase 3 trial compared to placebo.1-4,7,8 The most commonly reported adverse reactions were: rash 14 days post-dose, (the majority of which were mild to moderate); pyrexia (fever) within 7 days post-dose; non-serious injection site reactions within 7 days post-dose.¹⁶

Findings from the nirsevimab clinical trial program included a pre-specified pooled analysis of the Phase 3 MELODY trial (primary cohort) and the recommended dose from the Phase 2b trial, in which a relative risk reduction of 79.5% versus placebo (95% CI 65.9, 87.7; P<0.0001) was seen against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.5 This analysis also showed a relative risk reduction of 77.3% (95% CI 50.3, 89.7; P<0.001) against RSV LRTI hospitalizations.⁵

About RSV

RSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC).¹⁰ In the U.S., RSV is the leading cause of hospitalization in infants under 12 months.¹¹ Approximately 75% of infants hospitalized for RSV are born at term with no underlying conditions.^12-14 RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.¹⁰ Each year RSV infection leads to approximately 500,000 emergency department visits by children under 5 years of age, which represents 1 in 4 of all RSV-related doctor visits, according to the CDC.¹⁸

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com
Kate Conway | + 1 508 364 4931 | kate.conway@sanofi.com

References
1. Hammitt LL, MD et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa2110275.
2. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed December 2022.
3. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2.../results/NCT02878330. Accessed December 2022.
4. Griffin P, MD et al. (2020). Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556.
5. Simões, E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.
6. Wilkins, D, et al. Nirsevimab for the prevention of respiratory syncytial virus infection: neutralizing antibody levels following a single dose. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.
7. Domachowske J, MD et al. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022; 386 (9).
8. Clinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488 (MEDLEY). Accessed December 2022.
9. Synagis - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Available from: https://www.ema.europa.eu/en/d...t-information_en.pdf Accessed December 2022.
10. Centers for Disease Control and Prevention. RSV in Infants and Young Children. Centers for Disease Control and Prevention. December 18, 2020. https://www.cdc.gov/rsv/high-r...-young-children.html Accessed December 2022.
11. Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-S132. doi:10.1067/s0022-3476(03)00510-9.
12. Arriola CS, Kim L, Langley G, et al. Estimated burden of community-onset respiratory virus–associated hospitalizations among children aged <2 years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9(5):587-595.
13. Hall, C. B. et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics 132, e341-8 (2013).
14. Gantenberg, J. R. et al. Medically Attended Illness due to Respiratory Syncytial Virus Infection Among Infants Born in the United States Between 2016 and 2020.
15. Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/v...n/immunity-types.htm. Accessed December 2022.
16. European Commission. https://www.ema.europa.eu/en/d...t-information_en.pdf. Accessed December 2022.
17. Medicines & Healthcare products Regulatory Agency. https://assets.publishing.serv...14_November_2022.pdf. Accessed December 2022.
18. Hall, C. B. et al. The burden of respiratory syncytial virus infection in young children. New Engl J Medicine 360, 588–98 (2009)

Corim Industries Issues Allergy Alert on Undeclared Peanuts in Peanut Butter Hot Chocolate

For Immediate Release

January 18, 2023

Contact Information

Corim Industries
732-840-1670

Company Announcement

January 18, 2023, Corim Industries, USA of Brick, New Jersey is voluntarily recalling the following peanut butter hot chocolate products because they may contain undeclared peanut. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume the following products.

• Cocoa de Aroma - 24 ct k-cups assorted (12.7 oz carton containing Peanut Butter flavor 0.52 oz k-cups). All lots with Best By dates between January 11, 2023 and January 11, 2025
• Smart Sips - 24 ct k-cups (12.7 oz carton). All lots with Best By dates between January 11, 2023 and January 11, 2025
• Jersey Charm - 24 ct k-cups (12.7 oz carton). All lots with Best By dates between January 11, 2023 and January 11, 2025
• Colonial Coffee -12 ct k-cups (4.44 oz carton). All lots with Best By dates between January 11, 2023 and January 11, 2025

The recalled products were distributed to a limited number of resellers nationwide between January 11, 2021 and November 30, 2022. Only products with Best By dates between January 11, 2023 and January 11, 2025 are impacted. The Best By date is marked on the bottom of the carton.

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

The recall was initiated after it was discovered that a replacement flavoring ingredient from a different supplier may have trace levels of peanut that was not declared on bulk label or finished product label to downstream partners. However, testing conducted by Corim indicated that the levels may be below the limit of detection. The firm’s subsequent investigation identified the root cause as a temporary breakdown in the company's supplier documentation process. The process has been corrected and the company has instituted additional safety checks and corrective actions, including discontinuing the use of this particular flavoring ingredient.

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

Consumers with a peanut allergy who have purchased the affected products 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 732-840-1670 between 9:00am and 4:00pm EST, Monday-Friday.

Ameripack Foods LLC Announces Allergy Alert for Undeclared Soy and Egg in H-E-B Meal Simple Chocolate Chunk Brownie

For Immediate Release

January 11, 2023

Contact Information

Ameripack Foods LLC.
903-296-8206

Company Announcement

Ameripack Foods LLC of Hughes Springs, TX is issuing a recall for 976lbs. of brownies for H-E-B Meal Simple Chocolate Chunk Brownie 13 Oz due to an undeclared – Soy & Egg. People who have an allergy or severe sensitivity to soy or egg run the risk of serious or life-threatening allergic reaction if they consume this product.

The recall was initiated after discovering that trays of brownies were mislabeled on the back as Sopapilla Cheesecake, which does not list egg and soy allergens, on the product ingredient label.

There have been no injuries or illnesses reported to date.

The recalled product was available for purchase at H-E-B retail stores in the state of Texas.

What You Should Do: Consumers who have purchased this product should discontinue use immediately and return the product to the nearest H-E-B store for a full refund.

Consumer Contact Information: Consumers with questions regarding this recall should contact Ameripack Foods LLC. at 903-296-8206 (Monday -Friday 8:00am to 4:30pm Central Standard Time)

Consumers with questions or concerns about their health should contact their Physician.

Kids with Food Allergies (KFA) has a new look! We have redesigned our logo, our website, and our Safe Eats® Allergy-Friendly Recipe Collection to better help you manage your child’s food allergies with confidence.

We asked for feedback from our online community for parents, health care providers, and other KFA stakeholders. Based on that feedback, we redesigned the KFA website to improve accessibility and support for people managing food allergies.

Here are some of the changes you may notice:

• An updated design
• A new logo
• Easier-to-read text
• Streamlined menu navigation
• Improved search function

Children are at the heart of our work, and food allergies affect children of all populations and ages. We worked with Farida Zaman, an artist who specializes in children’s book illustrations, to create fun and diverse representations of children of various ages and cultures that we have incorporated into our new brand.

Along with the redesign of KFA, we also updated the Asthma and Allergy Foundation of America’s (AAFA) website as we celebrate 70 years of supporting people with asthma and allergies. KFA is the food allergy division of AAFA.

Members of our online community will also notice a new look. On the community you will find:

• Streamlined menu navigation – all content including forum topics, blogs, and surveys will be under one menu item titled “Posts”
• New subgroups will be easier to find and join
• A weekly “What’s New” digest email with a personalized summary of trending posts, upcoming events, and content by people you follow (watch for more information soon on how you can change your notifications)

Our goal is that the new kidswithfoodallergies.org will be a lively and inclusive hub for expanding the awareness and understanding of food allergies. Our website offers:

• Evidence-based information to help people manage food allergies
• A free, online support community to connect with other people who live with food allergies
• Updates about KFA’s projects, research, and advocacy efforts
• Resources for stakeholders, such as health care providers, community health organizations, and advocates, seeking to improve health outcomes

Our dedication to saving lives and reducing the burden of food allergies through support, advocacy, education, and research remains the same. KFA’s new brand is another step in our efforts to serve as a vital lifeline to families raising children with food allergies.

Daiso Issues Alergy Alert Tohato and Kashiwado Snacks

For Immediate Release

January 10, 2023

Contact Information

Daiso
833.888.1610
support@daiso-usa.com

Company Announcement

Daiso California LLC of La Mirada, CA is recalling the below listed Tohato and Kashiwado snacks due of undeclared allergen ingredients. People who have an allergy or severe sensitivity to almonds, peanuts, soybeans, milk, and shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

Tohato and Kashiwado Snacks were sold in Daiso stores in California, Washington, Nevada, Texas, New York, and New Jersey.

There have been no reported cases of allergic reaction to these products.

The recall was initiated after it was discovered that packaging did not adequately disclose the presence of all allergens. Sale of the products have been suspended, and Daiso California has pulled the products from store shelves.

Consumers who have purchased the below listed Tohato or Kashiwado snacks may return them to any Daiso store for a full refund. Consumers with questions may contact Daiso at support@daiso-usa.com or call toll free 833-888-1610.

Product Name - SKU - Missing Allergen

• TOHATO Caramel Corn - Boys Festival 80g - 4901940039432  - Almond, Peanut
• TOHATO Caramel Corn The Star Festival 80g - 4901940039647  - Almond
• TOHATO Harvest Sesame 94g - 4901940041312  Soybean, Sesame
• TOHATO Harvest Biscuits 4 kinds of nuts 94g - 4901940041558 - Soybean, Peanuts
• TOHATO Caramel Corn 80g - 4901940111107 - Almond
• TOHATO Almond Caramel Corn 70g - 4901940111114 - Almond
• TOHATO Bitter Caramel Corn 77g - 4901940111121 - Almond
• TOHATO Caramel Corn 2 pack 23g - 4901940111138 - Almond
• TOHATO Caramel corn 5 pack 105g - 4901940111145 - Soy
• TOHATO Caramel Corn 4 pack 40g - 4901940111152 - Almond
• TOHATO Nagewa Snack seaweed flavor 71g - 4901940112012 - Milk, Shellfish
• KASHIWADO Hitoritoiro Fly Beans Senbei - 4904036008213 - Peanut

The manufacturers of epinephrine devices have extended their U.S. savings programs through 2023.

Epinephrine is the only treatment for a severe allergic reaction known as anaphylaxis [anna-fih-LACK-sis]. It is only available through a prescription by your doctor. Most prescriptions come with two auto-injectors in one box.

People with food allergies should have epinephrine with them at all times. For children, this might mean that you need extra epinephrine auto-injectors. For example, your child may need to keep epinephrine at school, as well as some at after-school care. And you may want epinephrine devices that stay at home or go with you when you leave the house.

Here are savings offers for epinephrine auto-injectors and pre-filled syringes, as well as other ideas that may help you save money on drug costs. Your final copay, if any, may vary depending on your insurance plan and the deductibles for your family. Talk with your doctor about which epinephrine device is right for your family.

Savings Programs for Epinephrine Devices

• AUVI-Q^® – AUVI-Q has two assistance programs. Patients with commercial insurance may be able to get AUVI-Q for as little as $35 through the AUVI-Q Support Copay Program. Call 844-357-3968 for questions. Eligible patients without commercial insurance or Medicaid may be able to get AUVI-Q for no cost through the kaléo patient assistance program. Call 502-213-7601 for questions.
  
  
• EpiPen^® and EpiPen Jr^® – Use The EPIPEN^® Savings Card^® to reduce your out-of-pocket cost up to $300 per EPIPEN TWO-PACK® and/or EPIPEN JR TWO-PACK® carton per prescription refill (up to three cartons per prescription) and can be redeemed up to six times per calendar year. If you have questions, call 1-800-657-7613 (8 a.m.-8 p.m. ET, Monday-Friday). VIATRIS™ also has a patient assistance program.
  
  
• Authorized Generic of EpiPen^® and EpiPen Jr^® (epinephrine injection, USP) Auto-Injectors – Use the Epinephrine Injection, USP Auto-Injector Savings Card to reduce your out-of-pocket expenses up to $25 per generic two-pack. It can be redeemed for up to three cartons per prescription up to six times per calendar year. If you have questions, call 1-800-657-7613 (8 a.m.-8 p.m. ET, Monday-Friday). VIATRIS™ also has a patient assistance program.

• Epinephrine Injection USP Auto-Injector, Generic From Teva Pharmaceuticals Industries – If you have commercial insurance may save up to $30 per carton, up to three per prescription. If you have any questions, call 1-844-248-7949.

• Authorized Generic of Adrenaclick® Epinephrine Auto-Injector – If you have commercial insurance, you may get up to $10 off per pack. If you have any questions, call 330-757-8402.
  
  CVS Health sells these generic epinephrine auto-injectors at all CVS Pharmacy locations.
  
  
• SYMJEPI™ pre-filled epinephrine syringe – SYMJEPI™ is a portable syringe pre-filled with epinephrine. It is not an auto-injector. It comes in a two-pack and is available in 0.15 mg and 0.3 mg. With insurance, you may pay as little as $0 per prescription. If you don't have insurance, you may receive up to $100 off. If you are covered under a state-funded or federally funded program, you will not be eligible.

Other Possible Ways to Save Money

• Change insurance plans – If you are privately insured through work, see if you can shop around during open enrollment. If your family’s income is below a certain level, you might be offered Medicaid and/or your children might qualify under the Children’s Health Insurance Program (CHIP). This depends on your state. Visit Healthcare.gov or your state’s health insurance site.
  
  
• Switch to the “preferred” device for your plan – If you have prescription benefits, you may save on copays by agreeing to use the epinephrine device that is on the insurance “preferred” list.
  
  
• Use mail order – If you have prescription benefits, look into your plan’s mail order pharmacy options. This may give you a lower price or provide more two-packs of medicine for the same price. Many mail order prescription plans provide patients with a three month’s supply of medicine for the cost of two month’s copay.
  
  
• Talk with your doctor – If you have insurance, talk with your doctor. Sometimes they can write the prescription so that you can get more sets of medicine for one copay. Typically, a two-pack of epinephrine auto-injectors is considered a 30-day supply under your prescription plan. A doctor might write the prescription for six auto-injectors (three two-packs) to be filled at once. This could then be filled through the mail order pharmacy, as described above.
  
  
• Shop around – Call around to different pharmacies. Prices can vary, especially between large chain pharmacies and smaller independent pharmacies. Be aware that the pharmacies at club stores such as Costco and Sam’s Club are generally available to non-members too.
  
  
• Check with the local children’s hospital – This option may work if your child sees doctors at a major children’s hospital. Ask if they have any grants or patient assistance programs that can help pay for your child’s prescription.
  
  
• Talk with your employer – If you have medical insurance through an employer, contact their human resources department. Explain that your insurance will not cover a life-saving medicine for you or your child. Sometimes, if you have a generous employer, they will try to help you.
  
  

Originally published January 2015. Updated January 2023.