Popular Grocery Store Issues Multi-State Recall Over 'Serious' Health Risk
Big Y is warning consumers across multiple states of a potentially "serious" health risk if they consume certain fresh foods obtained in the grocery chain's Made-to-Order areas.
Made-To-Order Small Subs, Large Subs, 30' Super Subs, Wraps and Paninis purchased throughout Connecticut and Massachusetts (visit the FDA's website for the complete list of affected stores) on May 20 and May 21 may be contaminated with Salmonella, which can pose an especially "serious" and potentially fatal risk to the elderly, children, and immunocompromised individuals.
Otherwise healthy individuals may experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain if infected, with the risk for more severe illness if the bacteria enters the blood stream, which could lead to arterial infections, endocarditis or arthritis, according to the recall.
The recall was linked to the ongoing Bedner Growers Inc. Cucumber Outbreak, with the sliced cucumbers available at the impacted locations at risk of contamination. However, even if you purchased a Made-to-Order product without cucumbers in it during the affected time period, there is a risk of cross-contamination.
Prepackaged products for customer self-service were not impacted.
Upon learning of the link, Big Y immediately "ceased operation in all stores listed above, discarded product within the sub, wrap, and panini service line, then thoroughly cleaned and sanitized the service line."
No related illnesses have been reported so far, but folks who purchased Made-To-Order subs, wraps or paninis "are urged" to return them to your point of purchase or show your receipt at the place of purchase for a full refund.Popular Grocery Store Issues Multi-State Recall Over 'Serious' Health Risk first appeared on Parade on May 23, 2025
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Medscape
28 minutes ago
- Medscape
ACURATE Heart Valves Halted After Consequential Study
Boston Scientific has discontinued production of its ACURATE neo2 heart valves following the release of data showing the devices were linked to higher rates of all-cause death, stroke, and rehospitalization than were other commercially available valves. The company reported the decision in a May 28 regulatory filing. 'While data continue to support the performance of the ACURATE valve system when the product's optimized instructions for use are followed, this decision was made based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets,' Boston Scientific told Cardiovascular Business . 'Therefore, related commercial, clinical, research and development, and manufacturing activities will cease.' The company said it also would be halting production of its ACURATE PRIME valves, although the reason for that move was not clear. Disappointing Results The decision on the neo2 follows the publication May 21 of two articles from the study, one in the Lancet on the outcomes for patients and the other in the Journal of the American College of Cardiology on a relatively high rate of under-expansion of the valves. Despite its use in 50 other countries, ACURATE neo2 had not yet been approved by the US Food and Drug Administration. The Lancet study, which the company funded, involved 1469 patients undergoing transcatheter aortic valve replacement (TAVR). Its aim was to determine whether ACURATE neo2 was not inferior to its competitors. The randomized, controlled trial found ACURATE neo2 was associated with a 6.6% higher rate of a combined outcome of all-cause death, stroke, and rehospitalization after 1 year than was observed in a control group who received SAPIEN 3 or 3 Ultra or Evolut valves. The rates were also higher for each outcome (hazard ratio: 1.30 for all-cause death, 1.68 for stroke, and 1.57 for rehospitalization). Rates of cardiovascular mortality and myocardial infarction also were significantly higher at the same time point, according to the researchers. ACURATE neo2 was developed after its predecessor, ACURATE neo, a self-expanding valve for TAVR, did not achieve outcomes similar to those of SAPIEN and Evolut valves in randomized controlled trials. A problem with paravalvular leakage was found with ACURATE neo, prompting the development of neo2, which included a sealing skirt to prevent leakage, said Raj Makkar, MD, professor and associate director of the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, and lead author of both papers. 'The sealing skirt worked, and the valvular regurgitation rates were lower than in ACURATE neo, but they were nonetheless still higher than in the control valves,' said, who receives research support from Boston Scientific as well as other manufacturers of heart valves. In addition to poor results on the longer-term outcomes, the ACURATE neo2 was associated with a lower rate of success, determined by whether the device was installed and operated successfully, did not require further interventions, and was not linked to complications within 30 days. One result was positive for ACURATE neo2. 'The hemodynamics were actually quite good,' Makkar said. 'This trial also highlights that, when it comes to clinical outcomes, it's not just the hemodynamics. A lot of other things come into play.' 'The ACURATE neo2 valve is an easy-to-use valve, and smaller, observational studies had suggested that outcomes were good,' Makkar added. 'But you need the rigor of a randomized controlled trial. In a randomized setting, the clinical outcomes were not as robust as they were with the other valve platforms.' Valve Expansion a Concern In a post-study analysis, the researchers went back to see if they could find any contributing factors to the ACURATE neo2's poorer outcomes. When they reviewed angiograms taken during TAVR procedures, they noticed many of the valves had not fully expanded. 'We found that under-expansion was associated with more frequent primary endpoints in contrast to valves that were properly expanded,' Makkar said. 'If you modified the device such that the radial strength were better, and we did more aggressive pre- and post-dilation, we could perhaps improve the expansion of the valve,' Makkar said. 'But whether that would lead to better clinical outcomes remains to be investigated and proven…. Dilation might increase the risk of some complications, such as stroke and aortic root injury. It is reasonable to try to safely expand the valve, but we should not expand the valve at any cost.' Makkar reported research support from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and JenaValve.
Business Upturn
an hour ago
- Business Upturn
Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer
By GlobeNewswire Published on June 2, 2025, 10:15 IST Ad hoc announcement pursuant to Art. 53 LR At interim analysis, PSMAddition trial met its primary endpoint showing statistically significant and clinically meaningful benefit for Pluvicto™ plus hormone therapy versus hormone therapy alone, with positive trend in overall survival (OS) 1 Pluvicto is already approved for metastatic castration-resistant prostate cancer (mCRPC) and now shows potential in patients in an earlier disease setting 1,2 Novartis to present results at an upcoming medical meeting and, based on FDA feedback, will submit for regulatory review in the second half of the year Novartis is investigating a broad portfolio of RLTs in advanced cancers, including breast, colon, lung and pancreatic and is investing in multiple manufacturing facilities, with industry-leading infrastructure to accelerate delivery of RLTs to patients Basel, June 2, 2025 – Novartis today announced topline results from a pre-specified interim analysis of the Phase III PSMAddition trial. The trial met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) with a positive trend in overall survival (OS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC) treated with radioligand therapy (RLT), Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan), in combination with standard of care (SoC) versus SoC alone1. In PSMAddition, the SoC is a combination of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT)3. Almost all mHSPC patients ultimately progress to metastatic castration-resistant prostate cancer (mCRPC)4. There is a need for additional treatment options with novel mechanisms of action that further delay progression, prolong OS and improve disease control compared to the current SoC, while showing a favorable safety and tolerability profile. 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients,' said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer at Novartis. 'These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy. Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients.' This is the third positive read-out for Pluvicto in a Phase III trial, following the VISION and PSMAfore studies5,6. Results from PSMAddition in mHSPC show potential for treatment in an earlier setting with Pluvicto, which was recently granted US Food and Drug Administration (FDA) approval for earlier use in mCRPC, based on results from PSMAfore1,2. Novartis is harnessing the innovation of world-class scientists, strategic partnerships and one of the industry's most competitive pipelines to explore the potential of new, targeted therapies and precision medicine platforms to address the greatest unmet needs in prostate cancer. Data will be presented at an upcoming medical meeting and, based on FDA feedback, will be submitted for regulatory review in the second half of the year. About PSMAddition study PSMAddition (NCT04720157) is a Phase III, open-label, prospective, 1:1 randomized study comparing the efficacy and safety of Pluvicto in combination with SoC (ARPI + ADT) vs. SoC alone in adult patients with PSMA-positive mHSPC3. Patients randomized to the SoC alone arm are allowed to crossover to receive Pluvicto, upon confirmation of radiographic progression by blinded independent review committee (BIRC) and per the discretion of the treating physician3. The primary endpoint is rPFS, defined as the time to radiographic progression by PCWG3-modified RECIST V1.1 (as assessed by BIRC) or death3. The key secondary endpoint of OS is defined as time to death due to any cause3. About Pluvicto™ (INN: lutetium (177Lu) vipivotide tetraxetan) Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)5,7. After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein5,7. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death7. Pluvicto is the only PSMA-targeted agent approved for PSMA-positive mCRPC and is the first targeted RLT to demonstrate a clinical benefit for patients with PSMA-positive mHSPC1. Novartis is investigating Pluvicto in earlier stages of disease, including oligometastatic prostate cancer (PSMA-DC, NCT05939414). Novartis and radioligand therapy (RLT) Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation and applying it to advanced cancers, RLT is designed to deliver treatment directly to target cells, anywhere in the body8,9. Novartis is investigating a broad portfolio of RLTs, exploring new isotopes, ligands and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and prostate cancer and into breast, colon, lung and pancreatic cancer. Novartis has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production sites. To support growing demand for RLTs, we have expanded production capabilities in Millburn (NJ), Zaragoza (Spain), Ivrea (Italy) and a state-of-the-art facility in Indianapolis (IN). In Carlsbad (CA), Novartis is establishing its third US-based RLT manufacturing site to support expanded use of RLTs, create resiliency in its manufacturing network and optimize the delivery of medicines to patients on the West Coast. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'may,' 'could,' 'trend,' 'potentially,' 'upcoming,' 'progression,' 'progress,' 'investigating,' 'investing,' 'look beyond,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Pluvicto, or regarding potential future revenues from Pluvicto. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Pluvicto will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Pluvicto will be commercially successful in the future. In particular, our expectations regarding Pluvicto could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Data on file. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2025. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). identifier: NCT04720157. Updated March 5, 2025. Accessed June 2, 2025. Oing C, Bristow RG. Systemic treatment of metastatic hormone-sensitive prostate cancer—upfront triplet versus doublet combination therapy. ESMO Open 2023l doi: 10.1016/ Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. The Lancet 2024; doi: 10.1016/S0140-6736(24)01653-2. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). Accessed June 18, 2024. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment [published correction appears in AJR Am J Roentgenol. 2017 Oct;209(4):949. doi: 10.2214/AJR.17.18875]. AJR Am J Roentgenol. 2017;209(2):277-288. doi:10.2214/AJR.17.18264 Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In: Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper's Clinical Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249 # # # Novartis Media Relations E-mail: [email protected] Novartis Investor RelationsCentral investor relations line: +41 61 324 7944 E-mail: [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Insider
an hour ago
- Business Insider
Moderna announces FDA approved mNEXSPIKE, new vaccine against COVID-19
Moderna (MRNA) announced that the U.S. Food and Drug Administration, FDA, has approved mNEXSPIKE, a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention. 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' said Stephane Bancel, Chief Executive Officer of Moderna. 'COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health.' Confident Investing Starts Here:
