Category: Government

Government policies, social programs and politics

Categories
Business Government Healthcare International & World Lifestyle Science

FDA approves Bayer’s Ultravist® (iopromide) injection for contrast-enhanced mammography

  • Ultravist™-300, -370 is now the only contrast agent in the U.S. indicated to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound
  • Contrast-enhanced mammography (CEM) is an emerging modality combining digital mammography with the administration of a contrast agent1
  • Strategically expands Bayer’s portfolio in breast imaging, including contrast agents and injectors

 

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer announced today that Ultravist® (iopromide)-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography (CEM) – making it the only contrast agent approved for this indication. The product can be used to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to help identify breast lesions.1

 

The new FDA approved indication aligns with the recent increased focus on supplemental imaging needs for women at a higher risk for breast cancer, which may include the 40-50% of U.S. women older than 40 with dense breasts.2

 

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, Head of Radiology Research and Development, Bayer. “We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients.”

 

The approval expands upon Bayer’s focus on breast imaging, with a portfolio that also includes Gadavist® (gadobutrol) injection, a gadolinium-based contrast agent approved for use with MRI (Magnetic Resonance Imaging) to assess the presence and extent of malignant breast disease in adult patients. In 2019, the MEDRAD® Stellant FLEX Computed Tomography (CT) Injection System with Certegra® Workstation was also cleared in the U.S. for use in CEM. Through the use of iodine-based x-ray contrast agents, CEM can allow for better visualization of abnormalities in breast tissue that may not be visible with standard mammography.3

 

About breast cancer and contrast-enhanced mammography

In 2020, there were 2.3 million women diagnosed with breast cancer globally, according to the World Health Organization (WHO).4 Contrast-enhanced mammography (CEM) has been demonstrated to help with visualization of lesions in breast tissue and is a relatively low-cost breast imaging examination. CEM is easy to perform in everyday clinical practice and can be used in various clinical settings, such as when routine imaging produces inconclusive findings. It can also be a helpful tool when breast MRI is unavailable or contraindicated.5

 

About Ultravist

INDICATIONS and IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Intra‐arterial Procedures*: Ultravist® is indicated for: • Cerebral arteriography and peripheral arteriography in adults; • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults; • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.

 

Intravenous Procedures*: Ultravist® is indicated for: • Excretory urography in adults and pediatric patients aged 2 years and older; • Contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older; • Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.

 

*Specific concentrations and presentations of Ultravist® are recommended for each type of imaging procedure [see Dosage and Administration (2.2, 2.3, 2.4)] in the Full Prescribing Information]

 

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE

Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use.

 

Risks Associated with Intrathecal Use: Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Ultravist® is for intra-arterial or intravenous use only. Ultravist® is not approved for intrathecal use.

 

Hypersensitivity Reactions: Ultravist® can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. There is increased risk of hypersensitivity reactions in patients with a history of previous reaction to a contrast agent and known allergic disorders, or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and have emergency resuscitation equipment and trained personnel available prior to Ultravist® administration. Monitor all patients for hypersensitivity reactions.

 

Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after administration. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemia, and repetitive and/or large doses of Ultravist® . Use the lowest necessary dose of Ultravist® in patients with renal impairment. Hydrate patients prior to and following Ultravist® administration. Do not use laxatives, diuretics, or preparatory dehydration prior to Ultravist® administration.

 

Cardiovascular Adverse Reactions: In patients with cardiac and / or renal disease, hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist®. Hypotensive collapse and shock have occurred. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Use the lowest necessary dose of ULTRAVIST in patients with congestive heart failure. Always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.

 

Thromboembolic Events: Serious, in some cases fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiography procedures. During these procedures, increased thrombosis and activation of the complement system can occur. Risk of thromboembolic events can be influenced by: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications. To decrease thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases the risk of clotting. Avoid angiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

 

Extravasation and Injection Site Reactions: Extravasation can occur, particularly in patients with severe arterial or venous disease. In addition, injection site reactions such as pain and swelling at the injection site can also occur. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.

 

Thyroid Storm in Patients with Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of Ultravist®.

 

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age. Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. The safety and effectiveness of Ultravist® in pediatric patients younger than 2 years of age have not been established, and Ultravist® is not approved for use in pediatric patients younger than 2 years of age.

 

Hypertensive Crisis in Patients with Pheochromocytoma: Hypertensive crisis in patients with pheochromocytoma has occurred with iodinated contrast agents. Closely monitor patients when administering Ultravist® if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of Ultravist® necessary and have measures for treatment of a hypertensive crisis readily available.

 

Sickle Cell Crisis in Patients with Sickle Cell Disease: Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following administration and use only if the necessary imaging information cannot be obtained with alternative imaging modalities.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering Ultravist® to patients with a history of a severe cutaneous adverse reaction to Ultravist®.

 

Interference with Laboratory Tests: Ultravist® can interfere with protein-bound iodine test.

Common Adverse Reactions: Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

 

Please see Full Prescribing Information for Ultravist®.

About Gadavist

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):

  • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
  • To assess the presence and extent of malignant breast disease in adult patients.
  • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

 

Gadavist® is indicated for use in magnetic resonance angiography (MRA):

  • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

 

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk of NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
    • Acute kidney injury
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

 

Contraindication and Important Information about Hypersensitivity Reactions: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist®.

 

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

 

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

 

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.

 

Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

 

Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.

 

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).

 

Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

PP-ULT-US-0096-1 June 2023

______________________

1 Kimeya F. Ghaderi, Jordana Phillips, Hannah Perry, Parisa Lotfi, and Tejas S. Mehta. Contrast-enhanced Mammography: Current Applications and Future Directions. RadioGraphics 2019 39:7, 1907-1920.

2 Susan G. Koman. Breast Density on a Mammogram. Updated April 4, 2023. Retrieved June 12, 2023 from: https://www.komen.org/breast-cancer/risk-factor/breast-tissue-density/.

3 Contrast-enhanced Mammography: How Does It Work? William F. Sensakovic, et al. RadioGraphics 2021 41:3, 829-839.

4 World Health Organization. Breast Cancer Fact Sheet. Updated March 26, 2021. Retrieved May 26, 2023 from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.

5 Maxine S. Jochelson, Marc B. I. Lobbes. Contrast-enhanced Mammography: State of the Art. Radiology 2021; 299:36–48.

Contacts

Contact for media inquiries:
Jennifer May, 412-656-8192
Email: jennifer.may@bayer.com

Categories
Business Foodies/Tastylicious Government Healthcare Lifestyle Local News

Nature’s Energy issues allergy alert on undeclared milk in Children’s Chewable Colostrum products

Nature’s Energy of Pleasant Grove, Utah, has voluntarily recalled Children’s Chewable Colostrum because it may contain undeclared milk allergen.

 

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

 

Nature’s Energy Children’s Chewable Colostrum products sold online at www.naturesenergy.comExternal Link Disclaimer and www.amazon.comExternal Link Disclaimer

 

The following products are being recalled Childrens Chewable Colostrum Berry, Chocolate and Orange Creamsicle flavors. 180 count.

  • Berry Chewables, 180 count, UPC 804879183945 GTIN 860008676979, LOT # 660, Best By 02/24 and LOT # 694, Best By 12/24.
  • Chocolate Chewables, 180 count, UPC 804879183952 GTIN 860008676986, LOT # 661, Best By 02/24 and LOT # 695, Best By 12/24.
  • Orange Creamsicle Chewables, 180 count, UPC 804879183969 GTIN 860008676993, LOT # 634, Best By 08/23, and LOT # 693, Best By 12/24.

 

No illnesses or deaths have been reported to date in connection with these products.

 

The recall was initiated after it was discovered that the Colostrum containing product was distributed in packaging that did not indicate the presence of milk proteins.

 

Customers with a milk 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 801-785-2304 or send email to admin@naturesenergy.us from 8am-4pm MT, Monday-Thursday.

 

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

Categories
Government Local News Politics

Mercer County Clerk announces June 6 Election update

TRENTON, N.J. — Mercer County Clerk Paula Sollami Covello would like to remind all eligible voters that sample ballots have been mailed out for the upcoming June 6 Primary Election.

It is important for all registered voters to be aware that certain voting locations have changed since the last election. The Board of Elections made this change in order to consolidate voting districts.

She instructs all constituents to carefully review their sample ballots to avoid any confusion or inconvenience on Election Day.

They should  find  designated voting location, as the County encourage residents to visit the Board of Elections website here.

Early voting will be held from June 2 to June 4: Friday and Saturday from 10 a.m. to 8 p.m., and Sunday from 10 a.m. to 6 p.m. 

No matter where you live in Mercer County, you can vote your specific ballot in person at any of our county’s seven designated in-person early voting locations.

Early voting sites for the primary are as follows:

  1. TRENTON – Trenton Fire Department – 244 Perry St., Trenton NJ 08618*
  2. HAMILTON – Colonial Fire Company – 801 Kuser Road, Hamilton NJ 08619*
  3. LAWRENCE – Mercer County Lawrence Library – 2751 Brunswick Pike, Lawrence NJ 08648
  4. PENNINGTON – Pennington Fire Company – 120 Bromel Place, Pennington NJ 08534
  5. PRINCETON – Princeton Shopping Center – Unit #260, 301 N. Harrison St., Princeton NJ 08540
  6. EAST WINDSOR – Mercer County Hickory Corner Library – 138 Hickory Corner Road, East Windsor NJ 08520
  7. EWING – Mercer County Office Park – 1440 Parkside Ave., Ewing, NJ 08638

 

Voted ballots for the June 6 primary may be returned to any drop box location within Mercer County by 8 p.m. on June 6. They also may be returned to the Mercer County Board of Elections, located at 930 Spruce St., Lawrence, by that same deadline. Or, if a voter wishes to return a ballot by mail, the postage is prepaid by Mercer County. Ballots can be tracked here, NJ DOS – Division of Elections – Track My Ballot (state.nj.us).  To request an absentee ballot, visit NJ DOS – Division of Elections – Vote-By-Mail (state.nj.us).

For more information, visit the Clerk’s Election page, or the New Jersey Department of State – Division of Elections – NJ Voter Information Portal, or call the County Clerk’s Election Office at 609-989-6495. For polling location questions, or to become a poll worker, you may contact the Mercer County Board of Elections Office at 609-989-6522.

Categories
Business Culture Environment Government Lifestyle Regulations & Security Technology

AM Best to host briefing on cyber insurance trends, impact of AI and evolving threats

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best will host an analytical briefing on trends and challenges in the cyber insurance market, including the rise of artificial intelligence and the return of ransomware attacks, at 11 a.m. (EDT) on Tuesday, June 13, 2023.

During the event, titled, “Cyber: Moderating Pricing, Cautious Underwriting, Even as Risks Resurface,” the panel, made up of AM Best analysts and industry experts, will discuss the market’s performance in 2022 and key market indicators, such as pricing, capacity and reinsurance conditions. Other topics include cyber war exclusions and recent developments in risk modeling, as well as how AI is being harnessed not only by underwriters in the segment, but also by more-sophisticated cyber criminals.

 

The panel includes:

  • Shawn Ram, head of insurance, Coalition, Inc.;
  • Matthew Silley, cyber reinsurance broker, Lockton Re;
  • Sridhar Manyem, senior director, industry research and analytics, AM Best; and
  • Christopher Graham, senior industry analyst, industry research and analytics, AM Best;

Attendees can submit questions during registration or by emailing conferenceinformation@ambest.com. The event will be streamed in video and audio formats, and playback will be available shortly after the event.

 

To find out more about the webinar or to register, please visit http://www.ambest.com/conferences/Cyber2023/index.html.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates.

ALL RIGHTS RESERVED.

Contacts

Christopher Sharkey
Associate Director, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Environment Government Healthcare Lifestyle News Now! Science

New Jersey American Water completes acquisition of Egg Harbor City water and sewer systems

First acquisition in the State completed via the Water Infrastructure Protection Act adds more than 3,000 new customer connections for company and provides rate protection for residents

 

CAMDEN, N.J. — (BUSINESS WIRE) — New Jersey American Water announced today it has completed its acquisition of the water and wastewater systems of Egg Harbor City, N.J. for $21.8 million.

 

The sale of these systems, which serve approximately 3,000 customer connections combined, follows the approval of the New Jersey Department of Community Affairs and the New Jersey Board of Public Utilities, and is the first in the state of New Jersey to be completed through the Water Infrastructure Protection Act (WIPA).

 

The state’s WIPA legislation was signed into law in 2015. It permits the sale or lease of municipally owned water or wastewater systems that meet certain criteria. The New Jersey Department of Environmental Protection certified the city’s request to pursue the sale through the WIPA path in April 2019.

 

“This is a historic moment for New Jersey communities that simply do not have the resources or capabilities to adequately or efficiently maintain their own water and wastewater systems,” said New Jersey Assembly Majority Leader and WIPA sponsor Louis D. Greenwald.

 

“When my fellow legislators and I passed WIPA, our goal was to help struggling municipalities find alternatives to meet their needs by providing capital investment, expertise and financial assistance. It is incredibly gratifying to see Egg Harbor City be able to take advantage of this program to get the system upgrades they need in order to better service the community.”

 

Under the agreement, New Jersey American Water will invest $14 million in the first 10 years to make needed upgrades to the city’s water and wastewater systems, including $9 million in the first five years, while keeping rates stable for customers. Some of these projects include construction of an emergency interconnection with the New Jersey American Water regional system for resiliency, water and sewer main replacements, valve and hydrant replacements and wastewater pump station improvements.

 

“This agreement provides tremendous benefits for our residents. The sale of our city’s water and wastewater systems to New Jersey American Water will provide nearly $22 million to help the city pay off existing debt while leaving additional money to assist in other areas of the city’s budget. Additionally, the company is committed to investing $14 million into much-needed system improvements. All told, this means better infrastructure, stable water rates and millions in funds for the city, none of which would be possible without the sale of the systems,” said Egg Harbor City Mayor Lisa Jiampetti.

 

“We are ready to provide the residents of Egg Harbor City with reliable water and wastewater services, as we do for over 190 municipalities across the state,” said Mark McDonough, president of New Jersey American Water.

 

“Our plan includes rebuilding and modernizing the town’s water and wastewater infrastructure for continued quality and increased reliability while stabilizing rates and providing excellent customer service. Additionally, three of the city’s water and wastewater employees are joining our local operations team starting today.”

 

Customers will begin receiving information from New Jersey American Water within the next week to facilitate a smooth transition. Egg Harbor City residents will be able to take advantage of the company’s customer service benefits, including online account management and billing information, as well as its H20 Help to Others program for qualifying customers needing help paying their water and sewer bills. A dedicated webpage has also been created at www.newjerseyamwater.com/eggharborcity.

 

About New Jersey American Water

New Jersey American Water, a subsidiary of American Water (NYSE: AWK), is the largest investor-owned water utility in the state, providing high-quality and reliable water and/or wastewater services to approximately 2.8 million people. For more information, visit www.newjerseyamwater.com and follow New Jersey American Water on Twitter and Facebook.

 

About American Water

With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly traded water and wastewater utility company. The company employs approximately 6,500 dedicated professionals who provide regulated and regulated-like drinking water and wastewater services to an estimated 14 million people in 24 states. American Water provides safe, clean, affordable and reliable water services to our customers to help keep their lives flowing. For more information, visit amwater.com and diversityataw.com. Follow American Water on Twitter, Facebook and LinkedIn.

Contacts

Denise Venuti Free

Sr. Director, Communications & External Affairs

New Jersey American Water

856-955-4874

Denise.Free@amwater.com

Chelsea Kulp

Sr. Manager, Government & External Affairs

New Jersey American Water

856-745-1861

Chelsea.Kulp@amwater.com

Categories
Culture Foodies/Tastylicious Government Healthcare Lifestyle Local News Perks Programs & Events

Mercer County ADRC opens applications for senior farmers’ market nutrition program

Mercer County Executive Brian M. Hughes announced that starting June 1, the Mercer County Office on Aging/Aging & Disability Resource Connection (ADRC) will accept applications for the Senior Farmers’ Market Nutrition Program.

This program provides funding for the purchase of fresh, nutritious, unprepared foods like fruits, vegetables and herbs to low-income older adults.

“With foods provided from authorized farmers, the program not only helps increase the nutritional health of our communities, but also increases the demand for locally grown produce and boosts the income of farmers who produce and sell locally grown products,” Mr. Hughes said.

To qualify for this program, you must be able to verify that:

• You are 60 years of age or older
• You live in Mercer County
• Your income does not exceed $26,973 per year ($2,248 a month) if you are a single person or $36,482 per year ($3,041 a month) if you are a couple

Those eligible will receive $50 to spend for use at participating vendors at area farmers markets. Instead of paper vouchers that were distributed in previous years, older adults will now be assigned a QR code that will be easily accessible from their smartphones. Simply show the code (on a digital device or printed on paper from the Office on Aging/Aging & Disability Resource Connection) to the farm market vendor, who will scan it – that’s how easy the new QR codes are to use.

Funds will be distributed on a first-come, first-served basis. When you receive your QR code, you also will get a listing of participating markets and vendors. If you are taking a trip to a market, make sure to call ahead, as market days may change due to weather and produce availability.

If you, a family member or friend could benefit from this program, please call the Office on Aging/Aging & Disability Resource Connection at 609-989-6661. For more information, or to apply, you may also email adrc@mercercounty.org, or kturek@mercercounty.org.

The Mercer County Office on Aging/Aging & Disability Resource Connection (ADRC) is the federally designated agency responsible for the assessment, development, and funding distribution of programs/services for those 60 years of age or older in Mercer County.

Categories
Business Economics Government Healthcare Lifestyle Local News Science

CDC launches new funding for outbreak response

The Centers for Disease Control and Prevention (CDC) launched a new Notice of Funding Opportunity (NOFO) through the Center for Forecasting and Outbreak Analytics (CFA) to establish an outbreak response network for disease forecasting to support decision makers during public health emergencies.

 

The NOFO establishes a new program via cooperative agreement that is intended to support state and local decision-makers in developing and implementing new analytical tools that are best suited for their jurisdictions, based on the best available information. The program supports building and scaling needed capabilities, working with the private sector, academic, and jurisdiction partners, to use data effectively before and during public health emergencies. With these additional capabilities, our communities will be able to use data more effectively to detect, respond, and mitigate public health emergencies. Much like our ability to forecast the severity and landfall of hurricanes, this network will enable us to better predict the trajectory of future outbreaks, empowering response leaders with data and information when they need it most.

 

“Infectious disease outbreaks have and will continue to threaten our communities, friends and families,” said Dylan George, Director of CDC’s Center for Forecasting and Outbreak Analytics. “This network will increase our national capacity to use disease models, analytics, and forecasts to support public health action, prevent infections, protect people, and safeguard economies. The network will also provide desperately needed tools to fight outbreaks quickly and effectively in our communities, where critical response decisions are made.”

 

The new program will support advanced development of modeling, forecasting tools, and outbreak analytics through three critical operations: innovation, integration, and implementation. Funding recipients will work alongside CFA to establish a national network to support jurisdiction decision makers before and during future public health emergencies. Additionally, the cooperative agreement will fund recipients to plan, prepare, and respond to future infectious disease outbreaks.

 

The innovation component will support the development of a pipeline of new analytical methods, tools, or platforms for modeling efforts and will ultimately be used to provide information to public health decision makers.

 

The integration component will take the most promising approaches from the innovation pipeline and pilot test one or two approaches at the state, local, tribal, or territorial level to gauge the success of the technique in practical application by public health decision makers.

 

The third component, implementation, will take pilot projects that have proven successful and scale them for use across jurisdictions. The goal is to have new, effective analytical tools and approaches to deploy at the local level where critical public health action takes place.

 

Prospective funding recipients can apply here to one of the three components and may also apply to serve as coordinator between recipients for each of the three operational components.

 

The network is the next step for CFA to improving decision support at the jurisdictional level, where many key public health decisions are made during an infectious disease outbreak. This funding opportunity will amplify CFA’s mission to support decision makers during public health emergencies using advanced modeling, forecasts, and outbreak analytics.

 

For more information about these funding opportunities, visit CFA’s website before the July 14, 2023, application deadline.

Categories
Business Government Healthcare Science

Celltrion USA announces U.S. FDA approval of Yuflyma® (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira® (adalimumab) biosimilar

  • Yuflyma is FDA approved to treat eight conditions including Crohn’s disease and ulcerative colitis
  • Yuflyma is the first high-concentration and citrate-free adalimumab biosimilar to gain EU marketing authorization
  • Yuflyma offers citrate-free and high-concentration adalimumab formulation, providing an alternative treatment option for patients

 

JERSEY CITY, N.J. — (BUSINESS WIRE) — Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.1

 

Yuflyma is Celltrion’s fifth biosimilar and second anti-TNF biosimilar approved for use in the United States. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs.

“Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice,” said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. “As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for U.S. patients.”

 

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Professor Jonathan Kay of UMass Chan Medical School.

The approval of Yuflyma was based on a comprehensive data package of analytical, preclinical, and clinical studies, demonstrating that Yuflyma is comparable to the reference product in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and one year following treatment.2,3,4

Yuflyma will be available to patients in the U.S. starting July 2023.

Celltrion is also seeking an interchangeability designation from the U.S. FDA for Yuflyma, which is tentatively expected Q4 2024.

Notes to Editors:

About Yuflyma® (CT-P17, biosimilar adalimumab-aaty)1

Yuflyma was the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL, in the U.S. in July 2023, Celltrion additionally plans to launch two different types of dosage forms 80mg/0.8mL, 20mg/0.2mL.

About Interchangeability

An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by law, and often require additional clinical studies, which demonstrate that there is no additional risk or reduced drug effectiveness if a patient switches back and forth between an interchangeable biosimilar and a reference product, as compared to receiving treatment with just the reference product. When a biosimilar receives an interchangeability designation by the FDA, that means the biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.

Yuflyma® IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with YUFLYMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue YUFLYMA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with YUFLYMA prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections.
  • Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.
  • Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of TNF blocker treatment including YUFLYMA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.
  • In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with YUFLYMA.
  • In clinical trials of some adalimumab products, there was an approximate threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.

HYPERSENSITIVITY

  • Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

  • Use of TNF blockers, including YUFLYMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.
  • In patients who develop HBV reactivation, stop YUFLYMA and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of YUFLYMA therapy in this situation and monitor patients closely.

NEUROLOGIC REACTIONS

  • Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
  • Exercise caution in considering the use of YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.
  • Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.
  • Consider discontinuation of YUFLYMA therapy in patients with confirmed significant hematologic abnormalities.

HEART FAILURE

  • Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.
  • Exercise caution when using YUFLYMA in patients who have heart failure and monitor them carefully.

AUTOIMMUNITY

  • Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with YUFLYMA, discontinue treatment.

IMMUNIZATIONS

  • Patients on YUFLYMA may receive concurrent vaccinations, except for live vaccines.
  • It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating YUFLYMA therapy.
  • No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.
  • The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS

YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for:

  • Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
  • Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
  • Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
  • Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS
  • Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older
  • Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults

Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers

  • Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate
  • Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa

Please see full Prescribing Information for Yuflyma® (adalimumab-aaty)

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.

About Celltrion USA

Celltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: Inflectra® (infliximab-dyyb), Truxima® (rituximab-abbs), Herzuma® (trastuzumab-pkrb), Vegzelma® (bevacizumab-adcd), and Yuflyma®(adalimumab-aaty). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare’s management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion’s Annual Report.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Trademarks

Humira is a registered trademark of AbbVie.

Yuflyma® is a registered trademark of Celltrion, Inc., used under license.

References

1 Yuflyma US prescribing information (2023)

2 Yu K et al., Pharmacokinetic Equivalence of CT‐P17 to High‐Concentration (100 mg/mL) Reference Adalimumab: A Randomized Phase I Study in Healthy Subjects. Clin Transl Sci. 2021;14:1280-91.

3 Kay J et al., Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021;23(1):51.

4 Furst D et al., Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomised study in rheumatoid arthritis. Rheumatology. 2022;61(3):1385-95.

Contacts

For further information please contact:

Lindsey Lucenta

llucenta@apcoworldwide.com
+1 260-444-1306

Categories
Art & Life Business Foodies/Tastylicious Government Lifestyle

An FDA announcement claims that recently expired greens infiltrate some local markets

Lancaster Foods updates voluntary recall of various expired kale, spinach and collard green products

 

 

Summary:

Company Announcement Date: May 12, 2023
FDA Publish Date: May 12, 2023
Product Type: Food & Beverages, Produce, Foodborne Illness
Reason for Announcement: Potential for Listeria monocytogenes
Company Name: Lancaster Foods
Brand Name: Robinson Fresh, Lancaster, Giant
Product Description: Kale, Spinach, Collard Green products

 

Company Announcement:

Lancaster Foods has updated their May 5, 2023 Recall notice to add one product (Lancaster Brand Spinach item #41714, “Best If Used By” date April 29, 2023).

 

Lancaster Foods is voluntarily recalling a limited quantity of 3 brands of already-expired Robinson Fresh, Lancaster, and Giant brand Kale, Spinach and Collard Green products produced at the company’s Jessup, Maryland facility. This recall is due to a possible health risk from Listeria monocytogenes. No related illnesses have been reported to date. The recalled products are beyond their “Best If Used By Date”.

 

Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Consumers with these symptoms should immediately consult their health care provider.

 

The recall was initiated after notification that a random sample of a single bag of Chopped Kale Greens product with a “BEST IF USED BY May 1 2023” date collected by the New York Agriculture and Markets Food Safety Division tested positive for the Listeria pathogen.

 

A listing of products subject to this recall are summarized at the end of this announcement. Products can be identified by using the UPC or Item Number codes and the Best if Used by Dates outlined in the table below.

 

These products were distributed through retailers and distributors in the states of Connecticut, Maryland, Massachusetts, New Jersey, New York, Virginia, and Pennsylvania. Retailers and distributors have been instructed to ensure the recalled products are removed from all inventories. Consumers who might still have the recalled products in their refrigerators should discard the items and they should not be consumed.

 

No other products distributed by Lancaster Foods have been recalled. Lancaster Foods is working collaboratively with the U.S. Food and Drug Administration on this recall.

 

The safety and integrity of products distributed by Lancaster Foods are a top priority and taken very seriously.  Lancaster Foods regrets any inconvenience and concern this recall may cause.

 

AFFECTED PRODUCT: 

Item Number  Brand  Pack/ Size  UPC Codes  Description  Best If Used By Date
00682 ROBINSON FRESH 8 /
16 OZ		 0-95829-60015-9 KALE GREENS May 01 2023
00619 ROBINSON FRESH 6 /
32 OZ		 0-95829-60016-6 KALE GREENS May 01 2023
55423 LANCASTER 20 / 4 OZ N/A CHOPPED KALE May 01 2023
78983 GIANT 12 / 8 OZ 6-88267-09813-0 CURLY LEAF SPINACH April 29 2023
00684 ROBINSON FRESH 8 /
16 OZ		 0-95829-60006-7 COLLARD GREENS May 01 2023
01907 GIANT 8 /
16 OZ		 6-88267-05311-5 COLLARD GREENS May 01 2023
41714 LANCASTER 12 / 10 OZ 8-13055-01145-3 SPINACH April 29 2023

 

 

Company Contact Information

Customers who have any questions about the recall may contact Lancaster Foods Customer Service at 877-844-3441 Monday through Friday 8:30 a.m. to 4:00 p.m. EDT.

Categories
Economics Education Government Lifestyle News Now! Politics Regulations & Security

Democrats recently seek to explain the debt ceiling crisis

The debt ceiling is the cap on the amount of money the U.S. government can borrow to pay its debts, explains Stefanie Conahan, an insider Democrat.

In a matter of weeks, the federal government will exceed this legal borrowing limit. And it’s not hyperbole to say that if Congress doesn’t raise the debt ceiling, it would be catastrophic for our economy and American families, she shared.

Historically, raising the debt ceiling is a bipartisan exercise in Congress. But on May 16, House Republicans were demanding draconian cuts to federal aid in exchange for voting to lift the debt ceiling. They’d rather tank the economy and throw millions of Americans into poverty than make good on our country’s financial obligations.

In the Off the Sidelines Spotlight, we’ll explore the debt ceiling, debunk the GOP talking points, and break down where we go from here.

If you remember one thing, it’s this: House Republicans are shirking their responsibilities—to American families, to our economy, to their oath of office—by refusing to vote to raise the debt ceiling.

So let’s cut through the noise. We’re breaking down what Republicans are saying about the debt ceiling—and then giving you the facts.

 

WHAT REPUBLICANS ARE SAYING: “House Republicans should not have to vote to raise the debt ceiling because WE don’t support new initiatives proposed by the Biden administration.”

THE TRUTH: Raising the debt limit has ABSOLUTELY NOTHING to do with new spending. It is purely backward-looking. In fact, much of the debt in question was incurred BEFORE President Biden took office.

WHAT REPUBLICANS ARE SAYING: “We don’t want to raise the debt ceiling and authorize new spending.”

THE TRUTH: Once again, nope. That’s not how this works. Raising the debt ceiling enables the Treasury to borrow for spending already authorized by Congress.

WHAT HOUSE REPUBLICANS ARE SAYING: “We’ll only vote to lift the debt ceiling if we make massive cuts to federal spending.”

THE TRUTH: Well, that’s true. House Republicans passed legislation that would increase the debt ceiling in exchange for cuts to federal spending for critical programs. That includes kicking one million seniors off Meals on Wheels, eliminating 30,000 law enforcement jobs, and gutting veterans health care. Not to mention cuts to Head Start, cancer research, housing assistance for low-income families, and more.

WHAT REPUBLICANS ARE SAYING: “Not raising the debt ceiling would be a DISASTER for the U.S. economy.”

THE TRUTH: We’re 100% in agreement with Republicans there. Failure to raise the debt ceiling would be catastrophic. Defaulting on our nation’s debts could mean:

  • Seniors could miss social security checks. Without social security, almost 22 million Americans would fall into poverty.

  • Veterans benefits could be delayed, and military service members could stop receiving paychecks.

  • Our country’s credit could be downgraded, spiking interest rates. That could raise mortgage, car and credit card payments.

  • According to Moody’s Analytics, stock prices could fall by roughly 20 percent, wiping out $10 trillion in household wealth and devastating the 401k and retirement accounts of millions of Americans.

 

SPREAD THE WORD: We need to make it crystal clear that Republicans ALONE are responsible for the debt ceiling crisis. By REFUSING to vote on a bipartisan basis, they’re putting partisan games over American families and our economy.

 

Read link below for more:

New York Times Editorial Board: Are Republicans willing to raise the debt ceiling?

 

 

— Stefanie Conahan

(team@kirstengillibrand.com)