FDA announces large-scale recall of popular deodorants
According to the agency, more than 67,000 cases of roll-on deodorants are affected by the recall, which was prompted by deviations from Current Good Manufacturing Practices (CGMP) — a set of industry standards that ensure quality and safety in pharmaceutical and personal care product manufacturing.
The recalled items include:
Power Stick for Her Roll-On Antiperspirant Deodorant Powder Fresh, 1.8 oz (53 mL)n
Power Stick Invisible Protection Roll-On Antiperspirant Deodorant Spring Fresh, 1.8 oz (53 mL)n
Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant, 1.8 oz (53 mL)n
The deodorants were distributed across the United States. Consumers are encouraged to check the FDA's website for specific lot numbers tied to the affected products.
While no press release has been issued by A.P. Deauville at this time, the recall is ongoing, and the FDA continues to monitor the situation.
'Recalls are important because they protect the public from products that may cause injury, illness, or even death,' the FDA stated in its notice. The agency emphasizes that staying informed about product recalls is essential for consumer safety.
Recalls can be initiated voluntarily by a manufacturer or at the request of the FDA. The agency notes that while many recalls result in products being pulled from the market, some issues can be corrected without removing products from distribution.
Between 2014 and 2024, more than 83,000 FDA-regulated products were recalled in the U.S.
For now, consumers in possession of the affected deodorants are advised to stop using them and refer to the FDA's recall database for next steps.
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Arab Times
6 days ago
- Arab Times
FDA announces large-scale recall of popular deodorants
NEW YORK, July 20: The U.S. Food and Drug Administration (FDA) has announced a major recall involving tens of thousands of Power Stick deodorants produced by A.P. Deauville due to manufacturing defects. According to the agency, more than 67,000 cases of roll-on deodorants are affected by the recall, which was prompted by deviations from Current Good Manufacturing Practices (CGMP) — a set of industry standards that ensure quality and safety in pharmaceutical and personal care product manufacturing. The recalled items include: Power Stick for Her Roll-On Antiperspirant Deodorant Powder Fresh, 1.8 oz (53 mL)n Power Stick Invisible Protection Roll-On Antiperspirant Deodorant Spring Fresh, 1.8 oz (53 mL)n Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant, 1.8 oz (53 mL)n The deodorants were distributed across the United States. Consumers are encouraged to check the FDA's website for specific lot numbers tied to the affected products. While no press release has been issued by A.P. Deauville at this time, the recall is ongoing, and the FDA continues to monitor the situation. 'Recalls are important because they protect the public from products that may cause injury, illness, or even death,' the FDA stated in its notice. The agency emphasizes that staying informed about product recalls is essential for consumer safety. Recalls can be initiated voluntarily by a manufacturer or at the request of the FDA. The agency notes that while many recalls result in products being pulled from the market, some issues can be corrected without removing products from distribution. Between 2014 and 2024, more than 83,000 FDA-regulated products were recalled in the U.S. For now, consumers in possession of the affected deodorants are advised to stop using them and refer to the FDA's recall database for next steps.
Arab Times
19-07-2025
- Arab Times
New study links COVID-19 vaccine to potential eye damage
NEW YORK, July 19: A new scientific study has found that Pfizer's COVID-19 vaccine may cause temporary changes in the eyes' corneal structure, raising concerns about long-term vision health, particularly for individuals with pre-existing eye conditions. Researchers in Turkey studied 64 participants who received both doses of the Pfizer-BioNTech vaccine and discovered measurable changes to the cornea's innermost layer, known as the endothelium. This thin cell layer is vital for keeping the cornea clear by pumping out excess fluid. The study was published Wednesday in the journal Ophthalmic Epidemiology. The scientists observed that, within two months of vaccination, participants showed a slight thickening of the cornea, a decrease in endothelial cell count, and greater variability in the size of these cells — all potential signs of short-term stress on the eye. 'These changes suggest the vaccine may temporarily weaken the endothelium, though none of the participants experienced vision problems during the study,' the researchers noted. The average corneal thickness increased from 528 to 542 micrometers — about a 2% change. Meanwhile, endothelial cell density dropped from an average of 2,597 to 2,378 cells per square millimeter — an 8% decrease. While this remains within normal limits for healthy adults, the decline could pose a risk for people with already low cell counts, such as those with prior eye surgeries, infections, or conditions like Fuchs' dystrophy. The study also found a drop in the proportion of endothelial cells with a healthy hexagonal shape, from 50% to 48%, and an increase in the coefficient of variation in cell size from 39 to 42 — further indicators of stress or damage. 'These changes are subtle and may not cause immediate harm, but they warrant monitoring, especially in individuals with compromised corneal health,' the authors stated. The research team did not recommend against COVID-19 vaccination but emphasized the need for further long-term studies to determine whether the observed changes persist or worsen over time. 'If these effects on the endothelium continue for years, they could contribute to eye diseases such as corneal edema, bullous keratopathy, or corneal decompensation — all of which can lead to permanent vision loss if left untreated,' the study warned. Specialists recommend that people with eye discomfort or blurry vision consult an ophthalmologist. A non-invasive test using a specular microscope can determine endothelial cell health. The study adds to a growing list of side-effect concerns linked to COVID-19 vaccines. In May, the U.S. Food and Drug Administration (FDA) expanded its warning labels on Pfizer and Moderna vaccines to include risks of myocarditis and pericarditis — types of heart inflammation — particularly in males aged 16 to 25. Despite these concerns, health authorities maintain that the benefits of COVID-19 vaccination continue to outweigh the risks for the majority of the population. The Turkish study involved 128 eyes (64 participants), with each subject undergoing full ophthalmic examinations before receiving their first vaccine dose and approximately 75 days after their second. Researchers used high-precision tools — including Sirius corneal topography and the Tomey EM-4000 specular microscope — to assess corneal thickness and endothelial cell characteristics.
Kuwait Times
28-06-2025
- Kuwait Times
Stung by high prices, Americans make their own weight-loss drugs
SAN FRANCISCO: In what she calls the 'wild west' of obesity medicines, Missouri-based Amy Spencer is a pioneer. Each week the mother of two injects herself with weight-loss drugs, two of which are in clinical trials and not yet approved for sale by the US Food and Drug Administration. One comes mixed with tirzepatide, the active ingredient in Eli Lilly's Zepbound. Spencer, 50, is not part of any drug trial but mixes the cocktails herself, using tiny doses that she believes are safe. The total cost is about $50 monthly, as little as one-tenth of what she would expect to pay their makers for full treatment. The drugs – glucagon-like peptide-1 (GLP-1) weight-loss medicines – are manufactured and shipped from China, according to the packaging. She orders them through online vendors. Spencer belongs to a fast-growing group of Americans turning to what many call the 'gray market' for obesity medicines, bringing cheap active ingredients from China often labeled as for research purposes, according to import data and social media postings. It's a trend that drugmakers Lilly and Novo Nordisk, which makes Wegovy, say is dangerous as well as illicit. Reuters tracked online forums and interviewed seven people who said they bought obesity medicines through this market, including an attorney in Arizona who works for a state insurance agency, a retired nurse in Illinois and a Type 1 diabetic in Louisiana, who said the medicine helped cut her insulin intake by more than half. For more than a year there has been demand for cheap Chinese-made powders, exacerbated by limited health insurance coverage in the US. Buyers told Reuters the gray market received a boost from an FDA ruling last year that US compounding pharmacies – outsourcing facilities that create drugs in shortage – must stop selling obesity medicines more cheaply than the companies that developed them. Shipments of such active ingredients from Chinese entities not registered with the FDA jumped by 44 percent in January from the previous month, according to research by the Partnership for Safe Medicines, a public health group focused on the safety of prescription drugs. It said its findings are likely an undercount, because unregistered vendors may not disclose that their parcels contain medicines. Packages valued at less than $800 that enter the US under the de minimis rule are not included in the data. Nearly three-quarters of US adults are overweight or obese, according to government estimates, but a survey by nonprofit health policy research organization KFF found only about 8 percent say they have taken medicine for weight loss. Most of the gray market buyers Reuters interviewed had told their medical providers they were taking GLP-1 medicines but not where or how they bought them. Insurance coverage for weight-loss drugs has recently increased, but typically only covers branded versions, according to consulting firm Mercer. Many Americans have paid out of pocket for cheaper compounded drugs. Interest in taking small doses of the drugs has also spurred the online marketplace, buyers said. Taking to platforms including Reddit and Telegram for guidance, buyers import small quantities, often described as research materials to sidestep regulatory scrutiny. They swap advice for navigating the market, exchanging information on vendors, shipping and dosage, and sometimes clubbing together to cover the cost of testing the powders. One forum is called StairwayToGray. It has more than 21,000 members on Telegram and recently was gaining nearly 1,000 members weekly. It did not respond to Reuters' inquiries, and blocked access to the forum after receiving them. It has a website where it says it does not facilitate group purchases. 'This community is filling the gaps and being our own regulators, ensuring testing and access for everyone who needs it. Because you shouldn't have to choose between your health or your wallet,' it says. Spencer stores her stocks in her fridge and makes them up in the kitchen – carefully measuring sterile water, rolling the vial between her fingers until the powder dissolves, and drawing the liquid into a syringe before injecting it into her thigh or belly. She has lost 24 pounds. 'This is working so well for me. It's so easy. It's cheap,' said Spencer, who assumes her health plan wouldn't cover the drugs. 'I don't know what I would do without this medicine.' Very dangerous In February, 38 US state and territory attorney generals wrote the FDA seeking action against illegally sold weight-loss medicines, including 'research purposes only' ingredients from China. 'Much like with counterfeit versions, these active ingredients come from unregulated, undisclosed sources ... and pose risks of contamination and inclusion of foreign substances,' they said. Shabbir Safdar, executive director of the Partnership for Safe Medicines, said unapproved drugs can have problems with sterility, purity and consistency. 'It can be very dangerous. You're playing the role of your own doctor, pharmacist, and FDA inspector,' he said. Of those interviewed, only Spencer reported any problems: She once got her math wrong and overdosed, resulting in several days of severe flu-like symptoms. Lilly said it had taken many steps to address patient safety risks posed by the proliferation of unsafe or untested tirzepatide. The company said it is filing lawsuits, educating consumers and working with social media companies to identify and remove posts that promote unsafe products, including those described as 'research use only'. 'We will continue to take action to stop those who threaten patient safety and urgently call on regulators and law enforcement to do the same,' a Lilly spokesperson told Reuters. Novo Nordisk also said it continues to take action against entities that violate laws and regulations and put patient safety at risk. America's Poison Control agency, which maintains the nation's poison data surveillance system and monitors GLP-1 exposures, said it could not reliably track cases involving unregulated 'research chemical powders' because they are sold under various names and formulations. The FDA's goal is to stop illegal sales of pharmaceutical medicines at the border, said George Karavetsos, former director of the FDA's Office of Criminal Investigations and co-author of the imports study. But understanding the true nature and intended use of small parcels arriving from China can be difficult, and the FDA rarely seeks charges against consumers for personal use, he said. — Reuters The FDA said it urges consumers to buy from licensed pharmacies and 'avoid products of unknown quality,' adding it was actively protecting consumers by intercepting illegal products at ports, and warning companies that market unapproved weight-loss medicines, including those mislabeled as 'for research purposes.' Although the forums show suppliers purportedly in China, Reuters was not able to verify where the drugs originate. A Reddit spokesperson said the site prohibits facilitating transactions involving drugs and regularly shuts down groups found to be doing this. Telegram said it removes 'more than a million' instances of harmful content each day, but did not comment directly. Microdose mistake Spencer has polycystic ovary syndrome and for years struggled with weight gain and hypertension. She decided to try obesity medicines after seeing claims on social media that microdosing them could give fewer side effects, and bought semaglutide, the active ingredient in Wegovy, from a compounding pharmacy for about $200 per month. She started on one-fifth of the lowest dose. Within days, intermittent joint pain she often suffered had dissipated: 'I didn't realize how badly I hurt until the pain was gone.' The cost would reach about $500 a month if she bought the drug from Novo, which recently introduced one-off discounts. After a week, Spencer said, her blood pressure dropped so low she thought she might pass out, so she stopped taking hypertension medicine. Her pressure stabilized and she lost three pounds. She wanted to understand more about microdosing, and turned to the gray market last summer. On Reddit, users told how another Novo drug in development, called CagriSema, had helped reduce inflammation and hunger pangs better than semaglutide. CagriSema is Novo's next-generation obesity drug candidate, still in clinical trials so not available to the public. It combines semaglutide with another molecule, called cagrilintide, which intensifies the hormone-mimicking effects to regulate blood sugar and reduce hunger. Spencer was intrigued. She found a US reseller saying they tested Chinese-made CagriSema through a third-party lab before selling it to Americans. On microdoses of CagriSema, Spencer could enjoy food in small quantities. 'I could say 'yes' because I knew I was only going to eat four bites.' In October, Spencer saw on Reddit that tirzepatide might also reduce inflammation. She placed a new order for vials that contained cagrilintide and tirzepatide combined, dubbed 'cagri-tirz.' Now each Monday, Spencer injects herself with tiny amounts of cagri-tirz. On Thursdays, she uses retatrutide, a new obesity medicine by Lilly, also in trials. As she was switching to cagri-tirz, Spencer made a dangerous mistake. She calculated her new dosage without realizing the concentration of cagrilintide in the combined vials was 10 times higher than she had taken previously. 'I was an idiot. I didn't do my math. Or rather, I did the math for the tirzepatide but not for the cagri,' she said. Almost immediately, she began vomiting. The reaction was so severe she had trouble moving. She forced herself to drink water but couldn't eat. After four days, when symptoms lifted, she had lost seven pounds. Despite the blunder, Spencer didn't consider returning to compounded versions of the drugs or abandoning them altogether. She is not regularly monitored by a healthcare provider, but says her treatment has led to a 'life-changing' reduction in weight, joint pain and blood pressure. 'Honor system' Gray-market buyer Marie, 41, shows how do-it-yourself drugmakers are organizing. She describes herself as a 'soccer mom' from the Midwest and asked to be identified by her middle name to protect her privacy. Last year she bought a compounding pharmacy's version of tirzepatide, paying about $470 monthly, and had lost more than 20 pounds when the FDA announced the ban on compounded weight-loss drugs. She began to worry about her supply. Browsing on Reddit, she discovered links to Telegram and a trove of detailed instructions from experienced users for buying weight-loss drug ingredients from China. Customers said they often paid with Bitcoin or through mobile payment service Venmo. After a month closely following the forums, Marie made a purchase in January. The package that arrived contained 20 small glass vials of white powder with red caps. There were no instructions. The vendor who advertised the package on Telegram said it came from China. Marie returned to the forums and joined a group of 52 other customers who paid a total of $1,020 to a Tennessee-based company called Peptide Test. Six members mailed in a vial each and the others chipped in their share of the fee. The lab found the samples were pure. Peptide Test declined to comment. 'It's an honor system,' said Marie. 'These groups are very supportive in a way I haven't seen on the internet before.' Before her first injection, Marie gave her husband details of what she had done. They agreed that if needed, he would disclose everything to the emergency medics. But she was fine. In March, Marie volunteered to organize testing a new order of tirzepatide. The group formed on Telegram after users received vials from the same vendor which they judged to be from the same batch based on the color of the caps. In all, 38 buyers agreed to chip in for the $1,300 bill, and decided by poll that five vials would be enough. Five people sent drugs to the lab, Janoshik Analytical in the Czech Republic, which found the vials contained tirzepatide, as purported, with purity between 99.78 percent and 99.85 percent. Janoshik's CEO, Peter Magic, is a former amateur weight-lifter. He said his company started out more than a decade ago testing performance-enhancing drugs for online buyers. Last year, it tested 3,050 samples of obesity drugs, up from just over 650 samples in 2023. 'We're testing hundreds of these every week,' said Magic, whose company helps customers navigate customs requirements for shipping chemicals. — Reuters
