Freeze-Dried Fruit Sold at Sam's Club Stores Recalled Nationwide
The product—Member's Mark Freeze Dried Fruit Variety Pack—was sold in 15-count boxes. The items were distributed between July 1 and July 25 via Sam's Club retail stores across 43 states.
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Boston Globe
5 minutes ago
- Boston Globe
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal. As of July 24, Marlborough-based Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said. Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure. Advertisement In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke. In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke. Advertisement As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said. A company investigation concluded that the safety issue 'is not associated with the design or manufacture of any component of the Watchman system. Heart devices, including defibrillators and other implants, are Boston Scientific's largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter. Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading.
13 minutes ago
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
WASHINGTON -- U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths. The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company's heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk. The agency said the company's Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA. Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal. As of July 24, Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said. Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants. Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure. In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke. In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke. As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said. A company investigation concluded that the safety issue 'is not associated with the design or manufacture of any component of the Watchman system. Heart devices, including defibrillators and other implants, are Boston Scientific's largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter. Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Yahoo
2 hours ago
- Yahoo
Teva's Ajovy becomes first migraine prevention drug approved for children
The US Food and Drug Administration (FDA) has approved a label expansion to Teva's Ajovy in certain children and adolescents, making it the first migraine prevention drug of its kind in the age group. Single-dose injectable Ajovy (fremanezumab-vfrm) is now approved for the preventive treatment of episodic migraine in children and adolescent patients aged between six and 17 years who weigh 45kg or more. Ajovy is part of a class of drugs called calcitonin gene-related peptide (CGRP) inhibitors, which block a protein involved in triggering migraines. The FDA approved Ajovy for adults in 2018. Israel-based Teva narrowly missed having the first CGRP-targeting drug approved for migraines at the time, following Novartis and Amgen's Aimovig (erenumab) approval earlier in the year. However, the therapy is not approved for children or adolescents, meaning its patient reach is now not as wide as Ajovy. One in ten children and adolescents in the US suffers from migraines, one of the most common neurological conditions. Paediatric migraine is often underrecognised and undertreated, disrupting lifestyle such as school attendance and social interactions. Episodic migraine refers to recurring severe headaches in children that do not occur daily but are frequent enough to interfere with daily activities. Ajovy is administered once a month and available for in-office or at-home use, offering an accessible treatment option for patients and their caregivers, such as parents. A higher-dose version, given every three months as three injections, is also available for adults. Teva's Phase III SPACE trial (NCT03539393) with the drug demonstrated statistically significant superior efficacy compared to placebo over three months in the paediatric population. The safety profile was consistent with that in the adult population – the most common side effects being itchiness, rash and drug hypersensitivity. Teva's global marketing business head Chris Fox said: 'Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood. 'With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.' The label expansion in children and adolescents gives Teva an edge over Novartis/Amgen, as well as Eli Lilly, whose Emgality (galcanezumab) – also a CGRP inhibitor – is also approved and on the market. Last year, Teva's migraine treatment Ajovy generated $507m in global sales, an 18% increase compared to the previous year. Analysis by GlobalData forecasts sales of $885m by 2031. Neither Amgen nor Lilly disclosed specific sales for their two products in 2024. GlobalData is the parent company of Pharmaceutical Technology. "Teva's Ajovy becomes first migraine prevention drug approved for children" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
