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Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk

Eye ointment products made in India and sold in the United States at Walmart, CVS and other retailers are being recalled due to a danger of infection.

Brassica Pharma Pvt. Ltd., of Maharastra, India, said it is recalling various eye lubricant products labeled Equate, CVS Health and AACE. Recalled products will have expiration dates ranging from February 2024 to September 2025.

"For...

Don't Use Smartwatches That Claim to Measure Blood Sugar, FDA Warns

Some Americans living with diabetes are using smartwatches and smart rings that claim to be able to track their blood sugar.

However, such claims from any device that does not pierce the skin are fraudulent and potentially dangerous, the U.S. Food and Drug Administration warned in an

  • Ernie Mundell HealthDay Reporter
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  • February 22, 2024
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  • Novo Nordisk Settles Lawsuits Over Copycat Versions of Ozempic, Wegovy

    Novo Nordisk has settled lawsuits against two Florida businesses that claimed to sell copycat versions of its popular weight-loss drugs Ozempic and Wegovy.

    The Danish drugmaker announced the settlements Friday, according to NBC News

    The move capped a legal battle that began in late November when the company filed 12 lawsuits against clinics, medical spas and compound...

    Cinnamon Processor in Ecuador Is Culprit Behind Lead-Tainted Applesauce, FDA Says

    A company in Ecuador that processed the cinnamon used in flavored applesauce pouches destined for the American market is the likely source of lead contamination in those products, U.S. investigators said.

    In an update to its investigatio...

    FDA Panel Tackles Faulty Pulse Oximeter Readings That Come With Darker Skin

    A U.S. Food and Drug Administration advisory panel on Friday addressed a continuing issue with pulse oximeters -- that they give less accurate readings for folks with darker skin.

    The devices are designed to measure oxygen levels in the blood, so correct readings are critical, experts say.

    During its daylong

  • Robin Foster HealthDay Reporter
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  • February 5, 2024
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  • FDA Warns of Dangerous Counterfeit Eyedrops

    Certain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday.

    The packaging for South Moon, Rebright and FivFivGo eyedrops mirrors the packaging for Bausch & Lomb's Lumify eyedrops, an over-the-counter product approved for red eye relief.

    However, samples of the knockoff South Moon...

    ADHD Drug Zenzedi Recalled Over Pill Mixup

    The maker of a drug used to treat ADHD and narcolepsy has recalled one lot of the medication after a pill mixup was discovered.

    The recall notice, issued by Azurity Pharmaceuticals Inc., states that one lot of Z...

    Phillips Suspends U.S. Sales of CPAP, Ventilator Machines After Recall

    Following a recall of millions of its breathing machines that began in mid-2021, Phillips Respironics announced Monday that it would halt sales of all such machines within the United States.

    The machines include continuous positive airway pressure (CPAP) devices used by people with sleep apnea, as well as ventilators used by other patients.

    The

  • Ernie Mundell HealthDay Reporter
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  • January 29, 2024
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  • Robitussin Honey Cough Syrup Recalled Due to Fungal Threat

    The maker of Robitussin has recalled eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult cough syrups.

    The products, which are made by Haleon, may be contaminated with a microbe, and "in immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminate...

    FDA Warns of Rare Secondary Cancer Risk With CAR-T Therapies

    WEDNESDAY, Jan. 24, 2024 (Healthday News) -- The U.S. Food and Drug Administration has told drugmakers to add a boxed warning to a type of cancer treatment called CAR-T therapy, saying the treatment itself may sometimes cause a secondary cancer.

    Still, FDA spokesperson Carly Kempler told NBC News

    FDA Clears Sickle Cell Drug to Treat Another Blood Disorder

    Casgevy, a groundbreaking treatment that was approved to treat sickle cell disease in December, was given the U.S. Food and Drug Administration's blessing on Tuesday to treat another inherited blood disorder.

    Casgevy is the first CRISPR-based medicine, where gene editing is used to develop the treatment, to be approved for use in the United States.

    The one-time dose permanently chan...

    FDA Review Supports Reclassifying Marijuana as Less Risky Drug

    Scientists from the U.S. Food and Drug Administration conclude in newly released documents that marijuana has less potential for abuse than other drugs with the same restrictions and it should be reclassified as a less dangerous drug.

    Not only that, the review found there is some evidence backing its use as a medical treatment.

    Right now, cannabis is classified as a

  • Robin Foster HealthDay Reporter
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  • January 15, 2024
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  • FDA Finds No Link to Suicide With Drugs Like Wegovy, Ozempic

    Drugs like Wegovy and Ozempic, which have become a wildly popular way to lose weight or battle diabetes, show no link to suicidal thoughts or actions, the U.S. Food and Drug Administration said Thursday.

    “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” an FDA

  • Robin Foster HealthDay Reporter
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  • January 12, 2024
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  • FDA to Import Syphilis Drug From France Amid Shortage

    Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker.

    In a letter from Laboratoires Delbert, the Paris-based company said it's working with the FDA to temporarily import 3.5 million ...

    Lead-Tainted Applesauce May Contain Another Toxin, Chromium

    Applesauce fruit puree pouches under recall and investigation for toxic lead levels may also contain another toxin, chromium, according to an update released Friday by the U.S. Food and Drug Administration (FDA).

    The products under recall are Wana...

    Cases of Lead Poisoning Linked to Fruit Puree Pouches Reaches 251

    At least 251 cases of lead poisoning linked to tainted fruit puree pouches have now been reported in 34 states, U.S. health officials said.

    That's up from 205 cases reported in the last weekly tally, the U.S. Centers of Disease Control and Prevention noted in its latest update

    Blue Ridge Beef Raw Pet Food Recalled Due to Salmonella Risk

    Blue Ridge Beef, a maker of raw pet foods, has announced it is recalling some of its products for kittens and puppies because of possible contamination with salmonella and listeria.

    After being notified earlier this month by the North Carolina Department of Agriculture and Consumer Services that health officials found salmonella and Listeria monocytogenes in certain products, the...

    FDA Warns of Counterfeit Ozempic

    The U.S. Food and Drug Administration has uncovered counterfeit Ozempic shots in the legitimate U.S. drug supply chain, and is warning patients to be on their guard.

    The FDA said Thursday that it has seized thousands of counterfeit dos...

    Unapproved 'Fat-Dissolving' Injections Are Leaving Patients Maimed, FDA Warns

    People are being maimed by unauthorized fat-dissolving injections meant to tighten up double chins and dissipate flab along the arms, thighs and stomach, the U.S. Food and Drug Administration warns.

    The shots are supposed to break down fat cells and reduce fat deposits in the areas around the injection sites.

    But adverse reactions from the unapproved injections are causing scarring,...

    Scent of a Woman's Tears Could Lower Anger Levels in Men

    A man becoming incredibly uncomfortable when a woman starts crying -- to the point he'll do anything to make her stop -- is a reliable old chestnut in TV and movies.

    But there appears to be a biochemical truth to that cliché, a new study reports.

    Women's tears contain scent-borne chemicals that block aggression in men, according to research published in the journal PLOS Biology...

    Over 200 Lead Poisoning Cases Now Linked to Tainted Fruit Puree Pouches

    At least 205 cases of lead poisoning linked to contaminated fruit puree pouches have now been reported in the United States, federal health officials report.

    That's up from 125 cases in the last weekly tally, with 33 states now reporting poisonings, the U.S. Centers of Disease Control and Prevention said in its

  • Robin Foster HealthDay Reporter
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  • December 21, 2023
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  • Cinnamon in Applesauce That Sickened Kids May Have Been Deliberately Tainted With Lead

    Cinnamon used in applesauce pouches that have been tied to high lead levels in kids may have been deliberately tainted with the toxic element, a source at the U.S. Food and Drug Administration says.

    "We're still in the midst of our investigation," Jim Jones, the FDA's deputy commissioner for human foods, told Politico. "But so far all of the signals we're getting lead to an inten...

    FDA Seizes 1.5 Million Illegal Vaping Products, Including Elf Bar

    Federal agents have seized more than 1.4 million illegal vaping products being smuggled into the United States from China.

    A three-day operation at Los Angeles International Airport resulted in the seizure of 41 shipments of illegal e-cigarettes worth more than $18 million, the U.S. Food and Drug Administration said.

    The products included the hugely popular brand Elf Bar, as well as...

    FDA Asked to Consider Party Drug MDMA as Treatment for PTSD

    A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD).

    When announcing the new drug application (NDA) filing on Tuesday, MAPS Public Benefit Corp. noted it has been studying the drug for this use for years. The FDA has 60 days to decide whet...

    Biden Administration Delays Decision on Menthol Cigarette Ban Amid Pushback

    The Biden administration has again delayed enacting a ban on menthol cigarettes following intense lobbying from the tobacco industry.

    Along with that pressure, other critics of the ban have warned that it might anger Black smokers, who use menthol cigarettes at far higher rates than whites -- just as President Biden gears up to run for re-election, administration officials told the Wa...

    After Salmonella Cases Double in a Week, Cantaloupe Recall Expanded

    MONDAY, Nov. 27, 2023 (Healthday News) -- Three more brands of cantaloupe have been recalled by U.S. health officials after salmonella infections linked to the fruit more than doubled in just a week.

    The case count now includes nearly 100 people in 32 states, with Arizona, Missouri, Minnesota, Wisconsin and Ohio having the highest number of illnesses reported. Two people have died in Minn...

    FDA Looking at Cinnamon as Source of Lead in Fruit Puree Products

    FRIDAY, Nov. 17, 2023 (Healthday News) -- The U.S. Food and Drug Administration said Friday it has found early evidence that cinnamon may be the source of high levels of lead in fruit puree pouches that have now sickened 34 children.

    The agency, in partnership with the U.S. Centers of Disease Control and Prevention, has been investigating illnesses linked to the consumption of Apple Cinna...

    FDA Moves Against Vape Products That Mimic Toys, Slushies and Appeal to Kids

    The U.S. Food and Drug Administration is taking action against e-cigarettes disguised to look like everyday items that appeal to young people.

    The FDA sent warning letters Thursday to seven online retailers that were selling unauthorized vape devices that look like drink containers, toys and phones.

    The products' design could appeal to young people and help them conceal e-cigarettes...

    Babies Are Contracting Salmonella After Handling Pet Food, FDA Warns

    FRIDAY, Nov. 10, 2023 (Healthday News) -- Two federal health agencies are investigating a salmonella outbreak linked to dog food that has sickened seven people in seven states, nearly all of them infants.

    On Thursday, the U.S. Food and Drug Administration

  • Robin Foster HealthDay Reporter
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  • November 10, 2023
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  • FDA Approves New Diet Drug Zepbound, a Version of the Diabetes Med Mounjaro

    A second injectable diabetes drug has been approved for weight loss in overweight and obese adults, the U.S. Food and Drug Administration announced Wednesday.

    The weight-loss drug Zepbound contains the same active ingredient, tirzepatide, as the diabetes drug Mounjaro. Both medications are made by Eli Lilly and Co.

    “Obesity and overweight are serious conditions that can be associa...

    FDA Will Pull Vet Drug Used in Pork Industry Over Cancer Concerns for Humans

    WEDNESDAY, Nov. 8, 2023 (Healthday News) -- The U.S. Food and Drug Administration said Tuesday that it plans to pull a veterinary drug used commonly in the pork industry because it might pose a cancer risk to humans wh...

    FDA Investigating Hospitalizations Linked to Counterfeit Ozempic

    The U.S. Food and Drug Administration has received at least three reports of people being hospitalized after taking counterfeit versions of the wildly popular weight-loss drugs known as semaglutides.

    At least one of these reports includes mention of a counterfeit version of the Novo Nordisk medication Ozempic, CBS News reported.

    Ozempic and Wegovy, another semaglutide medic...

    FDA Expands Investigation of Pureed Fruit Pouches

    Amid reports of more illnesses and additional product recalls, U.S. health officials have expanded their investigation into potentially lead-tainted pouches of apple cinnamon pureed fruit.

    The U.S. Food and Drug Administration said in an updated alert post...

    Tyson Chicken Nuggets Recalled Over Small Metal Pieces in Product

    Nearly 30,000 pounds of dinosaur-shaped chicken nuggets have been recalled by maker Tyson Foods Inc. after customers discovered small bits of metal in some of the nuggets.

    There has been one reported minor oral injury associated with consumption of the nuggets, which were produced on Sept. 5, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) said in a

    FDA Advisors Say New Gene Therapy for Sickle Cell Disease is Safe

    A new gene therapy for sickle cell disease was deemed safe by a U.S. Food and Drug Administration advisory panel on Tuesday, paving the way for full approval by early December.

    The FDA had already decided that the therapy, known as exa-cel, was effective.

    Developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland, exa-cel frees patients from the excruciatin...

    FDA Warns WananBana Fruit Puree Pouches May Contain Lead

    Certain pureed fruit pouches from WanaBana may contain dangerous levels of lead, the U.S. Food and Drug Administration has warned.

    Parents and caregivers should not buy or serve WanaBana apple cinnamon fruit puree pouches to children, the agency said in a recent

  • Robin Foster and Cara Murez and Ernie Mundell HealthDay Reporters
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  • October 31, 2023
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  • FDA Warns Eyedrops From Major Brands May Cause Infection

    Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant.

    Twenty-six eye care products are part of the alert. Contaminated products have the potential to cause eye infection and blindness because drugs applied to the eye can bypass some of the body's defenses.

    Those concerning the ...

    FDA Advisors to Weigh New Gene Therapy for Sickle Cell Anemia

    Patients with sickle cell disease may soon have two new treatments to try.

    On Tuesday, a U.S. Food and Drug Administration advisory committee will weigh the merits of a new gene therapy for the painful, inherited condition, which typically strikes Black people.

    The agency is expected to make a decision on that therapy in early December, and it also plans to decide on a second new tr...

    FDA Proposes Ban on Formaldehyde in Hair Straighteners Over Health Dangers

    The U.S. Food and Drug Administration has proposed a ban on the use of formaldehyde in hair relaxers over concerns about its link to respiratory problems and certain cancers.

    Right now, the FDA only discourages u...

    FDA Moves Closer to Banning Menthol Cigarettes, Flavored Cigars

    A proposed rule from federal regulators that would ban menthol cigarettes and flavored cigars has been sent to the White House Office of Management and Budget for final review.

    The U.S. Food and Drug Administration first announced the

    FDA Warns of Dangers of Compounded Ketamine for Psychiatric Use

    The U.S. Food and Drug Administration is warning consumers about risks of using compounded versions of the drug ketamine, often taken for psychiatric disorders.

    Compounded products are not evaluated by the FDA for safety and effectiveness. They're also not regulated like approved drugs, so they present a greater risk.

    “Although compounded drugs can serve an important medical need ...

    As Menthol Ban Nears, Big Tobacco Is Adding Synthetic Version to Cigarettes Instead

    Cigarette makers are using synthetic menthol substitutes in what appears to be an effort to skirt a looming federal menthol ban, researchers say.

    The menthol flavor appeals to younger and newer smokers, according to investigators at Duke Health in Durham, N.C., and Yale University in New Haven, Conn.

    These new “non-menthol” cigarettes are being introduced in states that have alr...

    FDA Will Begin to Regulate Thousands of Lab Tests

    Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools.

    Many Americans might have assumed that the FDA already had oversight of all medical tests; it does not.

    However, FDA Commissioner

  • Ernie Mundell HealthDay Reporter
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  • September 29, 2023
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  • FDA Panel Says No to Experimental ALS Drug

    An advisory panel to the U.S. Food and Drug Administration on Wednesday voted resoundingly against recommending a stem cell-based experimental treatment for ALS.

    Although the FDA isn't bound by the votes of its advisory panels, agency scientists have already penned a scathing review of the drug, called NuOwn.

    Th...

    FDA Adds Warning to Ozempic Label About Risk for Blocked Intestines

    Ozempic, a type 2 diabetes drug that has increasingly been used to help with weight loss, will now be labeled as having the potential to block intestines.

    The U.S. Food and Drug Administration recently made the label update for the drug made by ...

    Pfizer Restarts Production Plant in North Carolina Following Tornado Damage in July

    A Pfizer plant that makes vital drugs, anesthesia and hospital supplies has restarted production after a 10-week shutdown.

    The plant, located in Rocky Mount, N.C., sustained severe tornado damage on July 19, when roofs were ripped off and medications tossed around.

    "This expedited restart is a proud achievement for the Rocky Mount team; however, it is only the first step toward ful...

    Kraft Cheese Slices Recalled Due to Plastic Wrap Choking Hazard

    Kraft Heinz said it is recalling over 83,000 packs of its Kraft Singles American processed cheese slices because of a packaging defect in the plastic that wraps the cheese slices.

    A temporary issue developed on one of the wrapping machines, making it possible for a thin strip of individual film to stay on the cheese slice after the wrapper is removed. Having this film on the cheese could ...

    FDA Must Crack Down on Retailers Selling Tobacco to Teens: Report

    A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco.

    Among the report's findings were that the U.S. Food and Drug Administration needs to get tough on retailers selling tobacco to youth and should improve its oversight of online retailers.

    The FDA should also work with the Bureau of Alcohol, Tobacco, Firearm...

    FDA Wants More Data on First Needle-Free Antidote for Severe Allergic Reactions

    In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions.

    Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of...

    Diabetes Drug Maker Sues Over Compounded Versions of Mounjaro

    Another diabetes drug maker is taking legal action against businesses in several states, alleging that they're “fraudulently claiming” that their compounded products are the same as its medication.

    This time, it's Eli Lilly suing certain medical spas, wellness centers and compounding pharmacies over its medication Mounjaro.

    Mounjaro contains the active ingredient tirzepatide an...