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Associated Press
32 minutes ago
- Business
- Associated Press
UNCY Investors Have Opportunity to Join Unicycive Therapeutics, Inc. Fraud Investigation With the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)--Jul 19, 2025-- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Unicycive Therapeutics, Inc. ('Unicycive' or 'the Company') (NASDAQ: UNCY ) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Unicycive announced on June 30, 2025, that the FDA 'has issued a CRL [Complete Response Letter] for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.' The Company added that 'After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection.' Based on this news, shares of Unicycive fell by 29.85% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. View source version on CONTACT: The Schall Law Firm Brian Schall, Esq. 310-301-3335 [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: CLASS ACTION LAWSUIT PROFESSIONAL SERVICES LEGAL SOURCE: Schall Law Firm Copyright Business Wire 2025. PUB: 07/19/2025 02:19 PM/DISC: 07/19/2025 02:19 PM
Time of India
2 hours ago
- Business
- Time of India
Over 67,000 cases of deodorants sold at Walmart, Amazon recalled due to 'cGMP deviations'. What is it?
Over 67,000 cases of three types of Power Stick deodorant sold at Walmart, Amazon and Dollar Tree have been recalled due to 'cGMP deviations". This means the product did not meet manufacturing regulations by the Food and Drug Administration (FDA). On Thursday, the US Food and Drug Administration announced a nationwide recall of some Power Stick deodorants , manufactured by A.P. Deauville . Explore courses from Top Institutes in Select a Course Category Degree Public Policy MCA Healthcare others Leadership Management Data Analytics Data Science Cybersecurity Digital Marketing Product Management healthcare Data Science PGDM Others Design Thinking CXO Finance MBA Technology Artificial Intelligence Operations Management Project Management Skills you'll gain: Data-Driven Decision-Making Strategic Leadership and Transformation Global Business Acumen Comprehensive Business Expertise Duration: 2 Years University of Western Australia UWA Global MBA Starts on Jun 28, 2024 Get Details The recall was voluntary and involves 21,265 cases of Power Stick for Her Roll-on Antiperspirant Deodorant Powder Fresh; 22,482 cases of Power Stick Invisible Protection Roll-On Antiperspirant Deodorant Spring Fresh; and 23,467 cases of Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like The Top 25 Most Beautiful Women In The World Articles Vally Undo ALSO READ: Astronomer CEO Andy Byron's divorce bill revealed following Coldplay kiss cam controversy with HR chief The FDA states that recall is due to 'cGMP deviations.' The agency's website notes that CGMP stands for 'Current Good Manufacturing Practice' and these regulations 'make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.' Live Events The antiperspirants were distributed nationwide and sold at Walmart, Amazon and Dollar Tree. A.P. Deauville also makes shampoo, conditioner, lotion, body wash and facial wipes. What is CGMP? For the recall, the FDA enforcement reported cGMP deviations , which listed failures in adhering to current good manufacturing practices as the primary reason. According to FDA, the main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. ALSO READ: Barron Trump 'humiliated' at NYU? Professor, peers make shocking statement about US President's son "CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards," FDA says. Why is CGMP so important? A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMP requires testing, testing alone is not adequate to ensure quality, the FDA says. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. ALSO READ: Shooting in Washington's Renton leaves 'multiple victims', police launch investigation Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. However, it is important to note that no harmful substance was found in those products. "If a company is not complying with CGMP regulations, any drug it makes is considered 'adulterated' under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It does not mean that there is necessarily something wrong with the drug," according to FDA.
Time of India
6 hours ago
- Health
- Time of India
Deodorant recalled: Why FDA recalled 67,000 cases of Power Stick deodorants sold at Walmart, Dollar Tree, and Amazon
After blueberries, Greek yogurt, chocolates, and even water bottles, the FDA is now recalling deodorants! The Food and Drug Administration (FDA) has issued a voluntary recall of over 67,000 cases of Power Stick roll‑on deodorants manufactured by A.P. Deauville. The recall, which was announced on July 10, covers three popular variants – Power Stick for Her 'Power Fresh', Invisible Protection 'Spring Fresh', and Original Nourishing Invisible Protection. These products were sold widely through Walmart, Dollar Tree, and Amazon, affecting consumers across the United States. The recall was reportedly triggered by deviations from the FDA's Current Good Manufacturing Practices (cGMP), a red flag for production oversight and quality control, although no contamination was reported. Read on to know more. What caused the recall? On July 10, A.P. Deauville initiated the recall of 67,214 combined cases of Power Stick deodorant sold nationwide. For the recall, the FDA enforcement reported cGMP deviations, which listed failures in adhering to current good manufacturing practices as the primary reason. The FDA strictly enforces cGMP regulations to ensure products are consistently produced with accurate ingredients, proper strength, and no contamination. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Do you have a mouse? Desert Order Undo These regulations ensure that products are consistently manufactured in controlled environments, maintaining quality, safety, and efficacy. However, it is important to note that no harmful substance was found in those products. cGMP issues, although do not always indicate direct harm, any breach in manufacturing protocols – be it equipment calibration, hygiene, ingredient verification, or documentation control – can compromise product integrity, making this recall a critical decision. Why cGMP compliance matters Current Good Manufacturing Practices (cGMP) form a regulatory backbone ensuring that mass‑produced items, from medications to deodorants, meet rigorous safety and quality benchmarks. When deviations occur, whether in cleanliness, equipment calibration, or ingredient testing, consumer safety can't be guaranteed, even if no immediate harm is reported. Even in the absence of direct harm, any cGMP lapse poses potential quality risks, hence the proactive recall. Which items were recalled The recall includes three 1.8-oz roll‑on deodorants, each with specific lot numbers: Power Stick for Her Roll‑On 'Power Fresh' – 21,265 cases, e.g., lots 032026B011, 071226D381, 082826E402. Power Stick Invisible Protection 'Spring Fresh' Roll‑On – 22,482 cases, e.g., 031726A991, 071026D361, 111626G231. Power Stick Original Nourishing Invisible Protection – 23,467 cases, e.g., 032826B221, 070626D301, 111626G221. These Power Stick variants were sold nationwide via: Walmart – 3‑packs sold at around $21 Dollar Tree – 24‑packs for about $30 Amazon – available as individual or multi‑packs Consumers who purchased from any of these retailers are urged to inspect the UPC/barcode on the packaging, match the lot numbers printed beneath to see if their purchase is affected, and discontinue use if their deodorant is part of the recall.
Indian Express
7 hours ago
- Health
- Indian Express
US FDA announces major recall of over 67,000 cases of Power Stick deodorant
In a major recall issued by the US Food and Drug Administration (FDA), a popular deodorant brand A.P. Deauville was asked to recall some Power Stick deodorant for manufacturing defects as differences were found in the established manufacturing procedure. The FDA and A.P. Deauville issued a voluntary recall of over 67,000 cases of Power Stick deodorant last week that were sold across the country. The recall notice didn't specify the exact nature of issue that has taken place in the deodorant but stated that it is related to deviations with 'current good manufacturing practices' (cGMP). The recall was issued on July 10 and includes over 21,200 cases of the brand's 'power fresh'-scented Power Stick for Her Roll-On Antiperspirant Deodorant, over 22,400 cases of its 'spring fresh' scented Power Stick Invisible Protection Roll-On Antiperspirant Deodorant and over 23,400 cases of Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant. The Easton, Pennsylvania based company has not issued a statement regarding the recall of its products. A report by The Independent stated that the deodorant was available for purchase on Walmart for a pack of three for $21, and a pack of 24 deodorants was available on Dollar Tree for $30. E-commerce giant Amazon was also selling the product. The affected lot numbers for Power Stick for her roll-on Antiperspirant Deodorant are: 032026B011, 032226B031, 051626C241, 061526C882, 071226D371, 071226D381, 082526E341, 082826E402 The lot numbers for the affected Power Stick Invisible Protection Roll-On Antiperspirant Deodorant are: 031726A991, 041226B561, 062026C901, 062026C911, 071026D351, 071026D361, 071326D391, 111626G231 And the affected lot numbers for Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant are: 101225D781, 032926B281, 032826B221, 041126B531, 062226D011, 070626D301, 070626D333, 111026G051, 111326G091, 111626G221. Among the other SKUs in the personal care category, A.P. Deauville manufactures shampoos, conditioners, lotions, body washes, and facial wipes. (with inputs from The Independent)
Business Upturn
8 hours ago
- Health
- Business Upturn
The Pink Salt Trick Recipe for Fast Weight Loss Trend in 2025: Why ProZenith Is the Science-Backed Alternative
Chicago, July 19, 2025 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only. ProZenith is not intended to diagnose, treat, cure, or prevent any disease. Statements have not been evaluated by the FDA. Individual results may vary. Always consult a healthcare provider before beginning any supplement or diet strategy. Click Here to Explore the Full ProZenith Formula TL;DR: A trending pink salt recipe is sweeping TikTok as a supposed shortcut for weight loss. But what's really behind this viral drink, and why are experts raising concerns? In this report, we break down the trend's rise, the controversy around AI-generated celebrity endorsements, and how the new supplement ProZenith aims to support hormonal metabolism in a safer, research-backed way. In This Release, You'll Discover: What the 'Pink Salt Trick' recipe really is — and how it became a top 2025 TikTok trend Why AI-generated celebrity videos are being used to fuel misinformation The health risks of using saltwater as a weight loss tool What medical professionals and dietitians are saying about the trend Why women over 30 are most vulnerable to wellness misinformation How ProZenith compares biologically to salt-based hacks What makes ProZenith a better option for long-term metabolic balance Click Here to Learn More About ProZenith What Is the Pink Salt Trick Recipe Everyone's Talking About? The pink salt trick refers to a homemade drink recipe that's gone viral on TikTok and YouTube. It's typically presented as a 'weight loss drink' or 'morning metabolism hack' involving: The Recipe: 1/2 teaspoon pink Himalayan or Hawaiian salt Juice from 1/2 lemon 8–12 oz of warm or room temperature water Optional: 1 tsp apple cider vinegar or a dash of cayenne pepper The promise? Drink it first thing in the morning to 'reset metabolism,' suppress appetite, detox the body, and kickstart fat loss — without caffeine or fasting. Videos promoting the recipe often use phrases like: 'My pants are literally falling off!' 'This is what celebrities are using now.' 'Better than Ozempic!' But the science behind these claims is flimsy at best. And in many cases, entirely fabricated. Despite anecdotal praise, there are no peer-reviewed studies supporting the metabolic effects of pink salt water. Experts say any perceived benefits are likely due to placebo or temporary hydration effects, not real fat loss. The Deepfake Endorsement Controversy: Why the Internet Believed Oprah Promoted the Pink Salt Trick While the drink itself has gone viral, much of the attention in 2025 stems from AI-generated videos of Oprah Winfrey praising the recipe. These videos are so realistic that thousands believed they were real endorsements. In reality, Oprah never promoted the pink salt trick — and she condemned such deepfake scams in a 2022 Instagram video, stating: 'It is a fraud. It is a fake. It's a lie. I have nothing to do with any weight loss gummies or pink salt drinks that claim I use them.' Despite this, new videos using AI facial mapping and voice-cloning tools continue to circulate. Social media platforms have struggled to moderate these videos in real time, which has only contributed to their virality. This issue was spotlighted in Yahoo's creator series — What's Up with the Oprah Pink Salt Trick Recipe for Weight Loss? and What's the Deal with the Miracle Pink Salt Trick for Weight Loss? — where journalist Cassandra Brooklyn described how the fake endorsements kept showing up in her feed even though she never searched for weight loss tips. These articles were later mentioned in a broader industry discussion, including coverage in a GlobeNewswire consumer briefing on ProZenith. Read: Pink Salt Recipe for Weight Loss Spotlighted in New Consumer Briefing on Metabolic Reset with ProZenith Why the Pink Salt Trick Doesn't Work — and Might Be Harmful According to Dr. Alison Childress, a registered dietitian at Texas Tech University: 'Too much sodium can lead to water retention… this could result in weight gain — not fat, but fluid — especially in those who are salt-sensitive.' While the drink may provide a fleeting sense of fullness, there's no thermogenic benefit, hormonal regulation, or appetite suppression involved. Moreover, repeated use of this drink without iodine-rich salt can increase the risk of iodine deficiency, particularly among women of reproductive age. Iodine plays a critical role in thyroid hormone production, and inadequate levels can lead to fatigue, cold sensitivity, dry skin, and weight gain — all symptoms ironically counterproductive to the goals of the pink salt drink. Why Women Over 30 Are Most Vulnerable to These Trends Many women over 30 experience hormonal changes that affect metabolism, energy, and cravings. As stress levels increase and sleep quality declines, quick-fix trends feel even more attractive. Wellness journalist Cassandra Brooklyn explains: 'The pink salt videos started showing up in my feed even though I never searched for them. It made me wonder how many other women were seeing them too — especially those actively looking for help.' Research published in the International Journal of Behavioral Medicine shows that women exposed to 'rapid weight loss' messaging experienced higher body dissatisfaction and stress eating patterns. Compounding the issue is the algorithmic nature of social media, which can push diet content to vulnerable audiences based on a few clicks or likes. For women experiencing hormonal shifts and psychological stress, these seemingly innocent videos can drive harmful behaviors. Why ProZenith Was Formulated for This Exact Challenge ProZenith is a non-stimulant supplement formulated to help women manage appetite, cravings, and metabolic sluggishness without trendy hacks or viral gimmicks. What's Inside: Magnesium + Calcium – Regulate cortisol and stabilize energy – Regulate cortisol and stabilize energy BHB (Beta-Hydroxybutyrate) – Mimics ketone states to curb cravings – Mimics ketone states to curb cravings Turmeric Extract (95% curcuminoids) – Supports inflammation reduction – Supports inflammation reduction BioPerine® – Enhances nutrient absorption and delivery Unlike the pink salt trick, ProZenith doesn't rely on a placebo effect. Its ingredients have been clinically reviewed to support appetite hormones like ghrelin, reduce emotional eating triggers, and help restore metabolic rhythm in women after 30. Each dose is designed for consistency — not intensity. There are no stimulants, no crashes, and no 'flush' reactions. Just gradual, supportive metabolic regulation backed by emerging science and nutritional precision. Explore the Full Ingredient Breakdown Read: ProZenith Ingredients Researched: The Science Behind the Popular Formula Final Thoughts: Why This Trend Matters More Than It Seems The pink salt trick may look harmless. But it reflects a deeper pattern: emotional marketing, AI misinformation, and health shortcuts with no science behind them. ProZenith doesn't promise overnight results. But it does offer a research-supported daily strategy for women who are tired of fads and ready for clarity. If you're navigating hormonal shifts, emotional cravings, or just want to feel steady again — don't fall for digital hype disguised as healing. Support your body with something that respects biology. Click Here to Learn How ProZenith Works About the Brand ProZenith is a non-stimulant nutritional supplement designed to support women navigating hormonal appetite shifts, stress cravings, and metabolism slowdown. With clinically supported ingredients and zero caffeine, ProZenith offers a daily ritual for consistent metabolic support — without buzzwords, gimmicks, or fake endorsements. Customer Support ProZenith – Anti-Craving Support Without Stimulants Email: [email protected] Order Help: Phone (US): 1-800-390-6035 Phone (INT): 1-208-345-4245 Disclaimer This article is for informational purposes only. ProZenith is not intended to diagnose, treat, cure, or prevent any disease. Statements have not been evaluated by the FDA. Individual results may vary. Always consult a healthcare provider before beginning any supplement or diet strategy. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. 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