Latest news with #U.S.Food&DrugAdministration
Yahoo
11-07-2025
- Health
- Yahoo
Beloved Candy Shop Recalls Popular Chocolate Item That Poses Serious Health Risk
If you happen to have a sweet tooth, there's a recent food recall you should absolutely know about. According to a Company Announcement made on the U.S. Food & Drug Administration (FDA) website, Kilwins has recalled its Mocha Truffles due to the potential presence of undeclared pecans. "Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products," read the announcement, which was shared on June 25, Mocha Truffles were sold at Kilwins retail stores in the following cities:Orange Beach, AL (located at 4751 Main St, Unit F113) Coral Springs, FL Vero Beach, FL Winter Park, FL Thomasville, GA Annapolis, MD Portsmouth, NH Wilmington, NC (located at 16 Market St) Alexandria, VA The recalled Mocha Truffles were possibly sold at these nine Kilwins retail locations from April 28, 2025 through May 30, 2025. In addition to being sold out of the chocolate display cases in stores, the affected truffles may have also been packaged by the stores into any of the following retail packages: (The numbers listed before the product names would appear below the barcode on the back of the package.) 4564 Family Assortment 9 oz 4565 Family Assortment 14 oz 4566 Family Assortment 28 oz 4567 Family Assortment 42 oz 4574 Truffle Assortment 9.5 oz 43109 Truffle Assortment 8 oz 43110 Mocha Truffles 4.75 oz 44121 Truffle Assortment 4.75 oz For those who have an allergy or severe sensitivity to pecans, eating one of the recalled candies could prove dangerous. They run the risk of serious or life-threatening allergic reaction if they consume the chocolates. No illnesses have been reported to date in connection with Kilwins' Mocha Candy Shop Recalls Popular Chocolate Item That Poses Serious Health Risk first appeared on Men's Journal on Jul 8, 2025
Yahoo
11-07-2025
- Health
- Yahoo
Nationwide Recall Issued on Ritz Crackers Due to Potential Serious Health Risk
For many people, Ritz Peanut Butter Cracker Sandwiches are a go-to snack option when you're in need of something filling in a hurry or even if you just want a sweet and savory snack to unwind with. But if you recently bought certain varieties of the cracker sandwiches, there's a new recall you should absolutely know about. According to a Company Announcement shared on the U.S. Food & Drug Administration (FDA) website, Mondelēz Global LLC has issued a voluntarily recall across the country of four carton sizes of Ritz Peanut Butter Cracker Sandwiches manufactured in the U.S. and sold nationwide due to an undeclared allergen (peanuts).The cartons potentially contain individually wrapped packs that may be incorrectly labeled as "Cheese" variety even though the product may be a "Peanut Butter" that the affected product may contain peanuts, people with an allergy or severe sensitivity to the nuts may risk serious or life-threatening allergic reactions by consuming this product. Among the items affected by the recall are: 11.4 oz. RITZ Peanut Butter Cracker Sandwiches - 8 Count (8 x 1.38-oz. 6-pack carton) 27.6 oz. RITZ Peanut Butter Cracker Sandwiches - 20 Count (20 x 1.38-oz. 6-pack carton) 55.2 oz. RITZ Peanut Butter Cracker Sandwiches – 40 Count (40 x 1.38-oz. 6-pack carton) 27.3 oz. RITZ Filled Cracker Sandwich — 20-Count Variety Pack (20 packs of 10 Cheese 1.38-oz. packs and 10 Peanut Butter 1.38-oz. packs) Additionally, the individually wrapped packages misidentified as "Cheese" inside the affected cartons may be labeled "Ritz Cheese Cracker Sandwiches" and have a Retail UPC of 0 44000 00211 4. Consumers who have a peanut allergy should not eat the recalled products and should discard them Recall Issued on Ritz Crackers Due to Potential Serious Health Risk first appeared on Men's Journal on Jul 9, 2025
Business Upturn
07-07-2025
- Business
- Business Upturn
CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology
Business Wire India CorFlow Therapeutics AG (CorFlow), a pioneering company in the field of cardiac care targeting microvascular disease, today announced that the U.S. Food & Drug Administration (FDA) has approved the company's technology for investigational device exemption (IDE), which allows the pivotal clinical trial to begin at U.S. hospitals. CorFlow will now prepare these clinical trial sites to receive CorFlow systems, undergo training and begin enrolling patients being treated for heart attacks. The IDE Pivotal Trial, MOCA-II, is intended to prospectively validate the diagnostic accuracy of the proprietary CorFlow CoFl system in determining the presence or absence of microvsacular obstruction (MVO) during a primary PCI procedure. The primary endpoint compares the CoFI diagnostic reading to a reference standard of diagnosis by a cardiac MRI scan. The trial is approved to enroll over 200 STEMI patients at prestigious research institutions in both the United States and Europe. Having successfully completed the first-in-human MOCA-I trial in 2024, the MOCA-II study is the next critical step to bringing this unique technology into the hands of interventional cardiologists globally for the rapid diagnosis of MVO in heart attack patients. This in turn can enable new treatments and care pathways to the large MVO patient population with high rates of adverse clinical outcomes today. The CorFlow technology is designed to both diagnose MVO, plus serve as a localized drug delivery system for diagnostic and therapeutic agents, which is being researched independently. According to the US government Centers for Disease Control and Prevention, someone has a heart attack every 30 seconds in the USA, with about 800,000 cases reported annually in the country. Incidence and prevalence are similarly high in Europe. More than half of STEMI heart attack patients are shown to have MVO, and previous research has demonstrated that the presence of MVO is a major driver of adverse events. Currently, there are no technologies approved to diagnose MVO during an acute coronary intervention, and there are no approved therapeutic devices that specifically address MVO in the United States or Europe. Heart attacks and related heart disease remains a leading cause of death and disability worldwide. Paul Mead, CEO of CorFlow, said, 'The long history of interventional cardiology and heart attack care breakthroughs – going back over 100 years – is one of the great success stories of medical care progress, but the pioneers and luminaries of the field all agree that the work is unfinished. The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. We aim to bring this issue to light and show you can do something about it. This milestone brings us all one step closer to delivering on the promise to improving care for these people where we know we can do better.' MOCA-II is being led by world-renowned experts in heart attack care, Dr. Timothy Henry at The Christ Hospital in Cincinnati, Ohio (United States) and Professor Marco Valgimigli at Cardiocentro Ticino Institute, Lugano (Switzerland), who collectively have been published in over 1,000 peer-reviewed manuscripts in cardiovascular research. Dr. Tim Henry said, 'As an interventional cardiologist involved for decades in managing and researching STEMI patients, I am excited to get going on this pivotal trial with technology that could make such a significant impact to the outcome of our patients. I believe strongly that knowing with high confidence who has MVO at the point of care during a primary PCI procedure can make an immediate difference in how we manage our patients.' Professor Valgimigli added, 'Having played a significant part in MOCA-I first in human trial, I am thrilled to see the second-generation technology now available for the pivotal trial and am looking forward to contributing further to the scientific understanding of MVO in real time. While the medical community has diverse opinions on how to treat these patients, there is no question that proper diagnosis is the first step we need. I am optimistic that getting the CorFlow technology approved for everyday use by our peer interventional cardiologists can help move the field forward.' About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with subsidiary operations in both Italy and the United States. The company is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced in September 2024. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications for the unique patented technology. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
11-06-2025
- Health
- Yahoo
Breyers Ice Cream Is Being Recalled Nationwide—Here's What to Know
Breyers recalls mislabeled Rocky Road Ice Cream sold in Chocolate Truffle tubs. Affected cartons were sold nationwide, and they pose an almond allergen risk. Undeclared almonds can cause severe allergic reactions; seek help if symptoms U.S. Food & Drug Administration (FDA) announced a recall on a Breyers ice cream flavor sold nationwide, according to a recent report. This is due to mislabeling causing an undeclared allergen. The ice cream product being recalled is a 1.5-quart carton of Breyers Rocky Road Ice Cream packaged in a Breyers Chocolate Truffle Tub. While the tub bears the label of the chocolate truffle flavor, the lid is accurately labeled as the rocky road flavor. The impacted cartons have a printed best-by date of July 10, 2026, and UPC '077567457288.' Check your ice cream immediately, and if it matches the recall information, dispose of it or return to your place of purchase for a possible refund. This recall was recently classified as a Class II recall, meaning that the product "may cause temporary or medically reversible adverse health consequences." Those that have bought this mislabeled ice cream may unknowingly eat almonds, an undeclared allergen on the product. This can cause an allergic reaction as severe as anaphylaxis for people allergic to nuts. If you are showing signs of anaphylactic shock like nausea, vomiting, abdominal pain, hives or trouble breathing after eating this ice cream, call 911 immediately. Contact the FDA at 1-888-INFO-FDA (1-888-463-6332) for questions or to ask for additional information about this recall. Read the original article on EATINGWELL
Yahoo
11-06-2025
- Health
- Yahoo
Massive Shrimp Recall: Nearly 45,000 Pounds Affected Over Dangerous Listeria Risk
If you recently bought seafood, check your freezer. Bornstein Seafoods of Bellingham, Washington, just issued a recall of 44,550 pounds of cooked and peeled ready-to-eat coldwater shrimp meat due to potential listeria contamination, according to the U.S. Food & Drug Administration (FDA). The frozen product was distributed directly to distributors and retailers in California, Oregon, Washington, and British Columbia in Canada. Per the FDA, the product may have been further distributed and sold at retailers nationwide. The recalled item is packaged in 1- and 5-pound plastic bags under the Bornstein Seafoods brand. The lot code is printed in the lower-left corner of the master case labels and at the bottom on the backs of the bags. The affected 1-pound bags of shrimp meat have the UPC code 614133200246 and lot numbers A19008, A19009, A19019, A19026, A19030, A19032, A19037, and A19039. The affected 5-pound bags have the UPC code 614133200239 and lot numbers A19009, P11710, A18989, A19006, A19007, P11709, and P11710. During routine sampling, listeria was detected in an in-process shrimp sample in the food production environment. Bornstein Seafoods has stopped distributing the product as it investigates what caused the problem. Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. According to the U.S. Centers for Disease Control and Prevention (CDC), symptoms of an intestinal illness caused by listeria typically include diarrhea and vomiting. Symptoms usually start within 24 hours after consuming the contaminated food and last one to three days. If the bacteria has spread beyond the gut, people may experience more serious symptoms such as high fever, severe headache, stiffness, muscle aches, and fatigue. Symptoms of this type of illness usually start within two weeks after eating the contaminated food. If you have a fever and other symptoms of listeriosis, such as fatigue and muscle aches, contact your healthcare provider immediately. So far, no illnesses have been reported due to the recalled product. If you purchased the recalled product, return it to the place of purchase for a full refund. Consumers with questions may contact Bornstein Seafoods by emailing Andrew@ Read the original article on Martha Stewart
