Latest news with #cGMP
Hindustan Times
21 hours ago
- Health
- Hindustan Times
Over 67,000 cases of deodorant sold at Walmart, Amazon recalled. What to know
Keeping your armpits fresh just got a little more complicated. Late last week, the FDA issued a national recall for more than 67,000 cases of Power Stick deodorants after uncovering serious manufacturing problems. According to a report by The Cut, the products are made by A.P. Deauville, a Pennsylvania-based company that produces personal care goods sold at major retailers across the country. The FDA says the recall was prompted by violations of current good manufacturing practices (cGMP) - a legal set of standards companies must follow to ensure product safety.(Representative Image/Pixabay) Also read: Power Stick deodorant recall: Why thousands of units sold at Walmart, Dollar Tree, and Amazon have been recalled Why were Power Stick deodorants recalled? The FDA says the recall was prompted by violations of current good manufacturing practices (cGMP)—a legal set of standards companies must follow to ensure product safety. But the agency did not offer specifics. The reason behind this could be a contamination issue, mislabeling, or something else entirely; the FDA has yet to share it. But the reason was enough for the FDA to pull tens of thousands of deodorant bottles off the shelves. Also read: Lois Boisson breaks silence on Harriet Dart's bizarre 'deodorant' remark as fans express outrage The affected items include: Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Power Stick Invisible Protection Roll-On Spring Fresh Power Stick for Her Roll-On Powder Fresh The deodorants have been sold widely through retailers like Amazon, Walmart, and Dollar Tree, so check your bathroom cabinet if you have picked one up lately. The FDA is advising anyone who purchased a recalled item to either throw it out or return it to the store, according to The Cut. This is not the first instance of issues with deodorants. According to the reports, recently, there has been a viral panic over aluminium and cancer. FAQs: 1. Why were Power Stick deodorants recalled? The FDA flagged issues with how the deodorants were manufactured, citing violations of safety standards, but didn't specify the exact problem. 2. Which Power Stick products are affected? Three roll-on versions are part of the recall: Original Nourishing Invisible Protection, Spring Fresh, and Powder Fresh for Her. 3. Where were the recalled deodorants sold? They were sold nationwide at stores like Amazon, Walmart, and Dollar Tree. 4. What should I do if I bought one? You should stop using it immediately and either return it to the store or dispose of it safely. 5. Are recalled deodorants dangerous to use? The FDA hasn't detailed the risk, but recalls usually mean there's a potential health or safety concern, so it's best not to use them.
Time of India
a day ago
- Health
- Time of India
FDA recall alert: Power Stick deodorants pulled from Walmart, Amazon over major manufacturing lapse — Is yours affected? Know here
The United States Food and Drug Administration (FDA) has just announced a mass recall of over 67,000 Power Stick deodorants. These deodorants were manufactured by A.P. Deauville, and the FDA had ordered their recall due to deviations from current good manufacturing practices, or cGMP. This Power Stick deodorant recall is voluntary, and the exact breakup of the deodorants being recalled is as follows: 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. The FDA recalled the Power Stick Deodorants for not following cGMP The Power Stick Deodorants were recalled because they didn't follow Current Good Manufacturing Practices. Complying with these practices is intended to ensure that 'a product is safe for use, and that it has the ingredients and strength it claims to have.', per the FDA's own website. A recall is underway for tens of thousands of cases of Power Stick antiperspirant deodorant, according to the Food and Drug Administration (FDA).An enforcement report published by the agency showed A.P. Deauville launched a recall for over 67,000 cases of "power fresh"-scented… The FDA is among the most crucial regulatory agencies in the United States, and its ambit covers everything from food safety to over-the-counter pharmaceutical drugs, alongside vaccines and cosmetics, and grooming products such as deodorants. The manufacturer of the recalled Power Stick Deodorants, A.P. Deauville, has not publicly spoken out about the recall. The Power Stick deodorants were sold at major retailers nationwide The recalled Power Stick Deodorants have been sold nationwide through various online and big box retail stores including Amazon, Walmart, and Dollar Tree. It's quite likely that these deodorants will have fallen into the hands of many Americans. Due to the voluntary nature of the recall, it remains unclear whether all of the 67,000 deodorant sticks will find their way back to the retailers. The FDA has generally recommended that consumers either return any products marked for recall or simply discard them. To stay updated on the stories that are going viral follow Indiatimes Trending.
Business Wire
a day ago
- Business
- Business Wire
Avenacy Announces Launch of Dehydrated Alcohol Injection, USP Vials in the U.S. Market
BUSINESS WIRE)--Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced the launch of Dehydrated Alcohol Injection, USP in the United States as a therapeutic generic equivalent of Ablysinol®, which ended its market exclusivity in June 2025. Dehydrated Alcohol Injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. Each vial of Dehydrated Alcohol Injection contains 5 mL of ethyl alcohol ≥99% by volume and is supplied in a carton of five single-dose vials. Avenacy is currently the only supplier in the U.S. offering this product in a 5-pack configuration, providing healthcare facilities with greater flexibility in controlling inventory expenditures. 'As we continue to add to our rapidly growing portfolio, the launch of Dehydrated Alcohol Injection reflects our strategy of entering high-value markets with practical, differentiated solutions,' said Jeff Yordon, Co-Founder and CEO of Avenacy. 'The vial format of Avenacy's product supports safe handling, and the unique 5-pack presentation helps providers manage high-cost inventory more efficiently, reflecting our company's longstanding commitment to provide products that meet the needs of both patients and healthcare providers.' In line with Avenacy's mission to champion patient safety and streamline patient care, Dehydrated Alcohol Injection will feature the Company's highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Dehydrated Alcohol Injection, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. Dehydrated Alcohol Injection, USP had U.S. sales of approximately $71 million for the twelve months ending in March 2025. 1 Please see link for Full Prescribing Information. Ablysinol® is a registered trademark of Belcher Pharmaceuticals, LLC 1 Source: IQVIA About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the company is building a pipeline of high-quality, FDA-approved injectable products to ensure a resilient portfolio that can meet the needs of today's dynamic drug supply chain. With an experienced team, a commitment to quality and reliability, and product offerings designed to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit
Time of India
2 days 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
3 days 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.
