Children's cough syrup recalled nationwide over bacterial risk that ‘can cause death'
Medtech Products issued a nationwide recall of its Little Remedies Honey Cough Syrup after discovering a bacterium that can cause serious foodborne illness, according to a U.S. Food and Drug Administration advisory.
The voluntary recall affects five lots of the syrup, sold in 4-fluid-ounce amber bottles and distributed in stores — including Walgreens, Target, CVS, and Safeway — and online between December 14, 2022, and June 4, 2025.
The affected product bears the UPC 7-56184-10737-9 and includes lot numbers 0039 (exp. 11/2025), 0545 (01/2026), 0640 (02/2026), 0450 (05/2026), and 1198 (12/2026). The recall extends to all lots still within their expiration dates.
The bacteria found in the cough syrup, Bacillus cereus, can cause two distinct types of gastrointestinal illness. One type leads to nausea, vomiting and stomach cramps within hours of ingestion. The other manifests later, often with diarrhea and abdominal discomfort.
'Although healthy individuals may suffer only short-term illness, exposure to high levels of foodborne B. cereus can cause death,' the FDA warned.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Associated Press
2 days ago
- Associated Press
Live Love Life Hosts Largest National HIV Testing Day Event Across Central and Northeast Florida
Live Love Life Community Health Care Clinics will host its largest outreach effort to date, offering free, walk-in HIV testing at multiple locations. HOLLY HILL, FL, UNITED STATES, June 27, 2025 / / -- In recognition of National HIV Testing Day on Friday, June 27, Live Love Life Community Health Care Clinics will host its largest outreach effort to date, offering free, walk-in HIV testing at multiple locations across Central and Northeast Florida. The event will take place from 10:00 a.m. to 6:30 p.m., providing residents with a simple, fast, and confidential way to know their status and access supportive care. The testing sites will be located at the Live Love Life Clinic in Holly Hill. In addition, testing will be available at three off-site Walgreens and pharmacy locations: Walgreens #7241 in Deltona, Walgreens #4441 in Daytona Beach, and PHD Pharmacy in Orlando. All locations will offer free rapid HIV tests, with no appointments necessary, and results are available in minutes. 'At Live Love Life, we believe health equity begins wherever people are; not just inside a clinic,' says Mark Walczyk, CEO of Live Love Life. 'That's why today, we're meeting our community where they live, work, and gather; with free STI, HIV, and hepatitis C testing, health education, and real pathways to care. We invite everyone—whether you're curious, concerned, or simply care about your health - to stop by, bring a friend, and take one small step toward something better. Because this is more than public health, this is public love.' National HIV Testing Day is a critical moment to increase awareness around HIV prevention, testing, and treatment. Early diagnosis not only improves health outcomes but also plays a vital role in preventing the spread of HIV within the community. Through this event, Live Love Life aims to empower individuals to take charge of their health and encourage open conversations about testing and care. Beyond HIV testing, Live Love Life Clinics offer a wide range of inclusive health services year-round. These include hepatitis C testing and treatment, harm reduction support, PrEP and PEP education, LGBTQIA+ affirming care, and assistance with insurance enrollment and benefits navigation. The organization has established clinics in Holly Hill, Daytona, Ormond Beach, Deland, Orlando (Pine Hills and Universal), and Jacksonville (Downtown and Southside), with additional locations in development. Community members are encouraged to attend, bring friends or loved ones, and help spread the word about this life-saving initiative. No registration is required—just walk in and get tested. For more information about Live Love Life, please visit Charlie Walker Live Love Life email us here Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Associated Press
2 days ago
- Associated Press
SeaStar's QUELIMMUNE Can Cut Pediatric Sepsis Deaths In Half
By Meg Flippin Benzinga DETROIT, MICHIGAN - June 27, 2025 ( NEWMEDIAWIRE ) - SeaStar Medical Holding Corp. (NASDAQ: ICU), the commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, has made a lot of inroads on that front with QUELIMMUNE. A humanitarian medical device, QUELIMMUNE treats pediatric patients with acute kidney injury or AKI due to sepsis or a septic condition. The QUELIMMUNE therapy received U.S. Food and Drug Administration approval in 2024 after clinical trials showed it could cut mortality in half from 50% to 25%. 'QUELIMMUNE is designed to target the innate immune response. When patients get very sick, it becomes very dysregulated and cells go haywire and trigger something called the cytokine storm,' said Dr. Kevin Chung, MD, Chief Medical Officer at SeaStar Medical. 'The QUELIMMUNE device is designed specifically to target the cytokine storm at the source of the storm and it is associated with really good outcomes, especially in the pediatric population where mortality was cut in half from 50% to 25%.' From The Golf Course To The ICU That was the case for Kurt, a young student and avid golfer who has won multiple golf awards even though he underwent two open-heart surgeries before his sixth birthday. Knowing at an early age that he couldn't compete in the sports other kids were playing, Kurt picked up golf and never looked back. But over the years, Kurt faced doctor visits and surgeries, culminating in a near-death experience. At the time, Kurt was being treated at Cincinnati Children's Hospital Medical Center, where Dr. Stuart L. Goldstein, MD, the lead researcher for QUELIMMUNE's two trials that led to the device's FDA approval, worked. Kurt went in for a planned surgery to address an artificial replacement from his pulmonary to aortic valve, but had to be opened up again two days later as a result of blood leaking from his heart at the site of surgery. Kurt was put on a ventilator and went into multiple-organ failure, caught hospital pneumonia, and ultimately endured a 12-day coma. He developed AKI and respiratory failure, and doctors prepared to put him on ECMO (Extracorporeal Membrane Oxygenation), a more invasive type of support. But Dr. Goldstein spoke with the on-staff cardiologist and Kurt's family and suggested that the QUELLIMUNE therapy would be helpful for him. 'Kurt just started to turn around within 24 to 48 hours and did not require ECMO. Kurt left the ICU within two to three weeks and resumed going back to school and golfing,' says Dr. Goldstein. 'It was quite dramatic and is emblematic of when we see this work, which is far more often than not, patients turn around really really quickly when you wouldn't expect them to.' A Christmas Miracle For Kurt's father, David, the QUELIMMUNE therapy was a last-ditch effort to save his son, who had been languishing in the ICU for eleven days. Every night, the doctors would offer up different therapies and treatment ideas to stop his son's organs from failing and as luck would have it, one evening David and his nephew, who is also a doctor, ran into Dr. Goldstein outside of his son's room. Dr. Goldstein said he thought the QUELIMMUNE therapy could help with the inflammation and the family decided, given the apparently bleak prognosis, to give it a try, recalls David. From day two on, the inflammatory markers improved and continued to get a lot better. 'The inflammatory markers improved every day,' says David. His son was woken from the coma on day six of treatment, December 24. 'It was a Christmas miracle. He was awake and his numbers were improving,' his father said. Kurt had a tough recovery ahead of him when he woke up. He entered the hospital weighing 150 pounds and left at about 120 pounds. But by the beginning of March, he had regained his strength and energy and was golfing again. That is one of the other aspects of the QUELIMMUNE therapy that astonishes Dr. Goldstein, and makes him so optimistic that the device can treat other children with AKI. Typically 10% to 30% of pediatric patients who survive an AKI episode require chronic dialysis, but Kurt didn't. 'It is nothing I've seen before in clinical medicine in the last quarter century,' said Dr. Goldstein. Featured image fromShutterstock This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on further disclosureshere.
Business Wire
2 days ago
- Business Wire
Omeros Submits Narsoplimab Marketing Authorization Application to the European Medicines Agency for the Treatment of TA-TMA
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The MAA includes response-based analyses in narsoplimab-treated TA-TMA patients as well as analyses comparing overall survival between narsoplimab-treated patients and a well-matched external control group. Collectively, the results demonstrate a 61% response rate and, compared to the matched external control, a three-fold improvement in overall survival. The submission also includes outcomes in over 130 TA-TMA patients treated with narsoplimab under Omeros' expanded access program. Narsoplimab has been granted orphan drug designation by the EMA for treatment in hematopoietic stem cell transplant, enabling review of the MAA through the centralized procedure. This allows for a single marketing authorization to cover all EU member states and the European Economic Area countries of Iceland, Liechtenstein and Norway. The review procedure begins in mid-July and will follow a standard review timeline. The Committee for Medicinal Products for Human Use (CHMP) will conduct the scientific assessment and will issue an opinion at the end of the review. This opinion is typically adopted by the European Commission, with a final decision expected in mid-2026. The MAA submission follows the acceptance for review by the U.S. Food and Drug Administration (FDA) of the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of TA-TMA. The resubmission was assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025. About Narsoplimab Narsoplimab, also known as 'OMS721,' is an investigational fully human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 has been demonstrated to leave intact the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. A biologics license application (BLA) for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is under review by the U.S. Food and Drug Administration (FDA) and Omeros has submitted the corresponding European MAA. FDA has granted narsoplimab breakthrough therapy and orphan drug designations for TA-TMA and orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of TA-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of TA-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of TA-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for TA-TMA. About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the 'safe harbor' created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'goal,' 'intend,' 'likely,' 'look forward to,' 'may,' 'objective,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'slate,' 'target,' 'will,' 'would' and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated review process and timing of FDA action on the resubmitted BLA for narsoplimab in the United States, the anticipated review process and timing of EMA action on the MAA submission, the prospects for obtaining FDA or EMA approval of narsoplimab in any indication, and expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the potential commercialization of narsoplimab if it is approved by FDA or the EMA, are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in the narsoplimab BLA or narsoplimab MAA, inability to respond satisfactorily to information requests during regulatory review of the narsoplimab BLA or MAA, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether FDA and the EMA determine the registry used in our statistical analysis is sufficiently representative of TA-TMA patients, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading 'Risk Factors' in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2025 and in subsequent reports filed with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
