Over 67,000 cases of popular deodorant recalled nationwide
Per an enforcement notice, the recall includes three separate products: the Power Stick For Her Roll-On Antiperspirant Deodorant in the scent 'power fresh,' the Power Stick Invisible Protection Roll-On Antiperspirant Deodorant in the scent 'spring fresh,' and the Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant.
Over 20,000 cases of each product were recalled. The enforcement notice marked the reason for the recall as 'cGMP deviations', which stands for Current Good Manufacturing Practice. Per the FDA website, failure to meet CGMP regulations can lead to products being recalled.
The FDA notes, '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.'
The recall was announced on July 10 and is ongoing. While the products did not meet FDA standards, an exact reason for the recall was not disclosed. No injuries have been reported.
According to the enforcement report, the products were distributed nationwide. They are regularly sold at Dollar Tree, Amazon, and Walmart.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
19 minutes ago
- Yahoo
NC-based app uses AI to fight denied health insurance claims
A new app developed in North Carolina is using artificial intelligence to fight denied health insurance claims. The app, from Counterforce, lets residents upload their insurance coverage documents along with their denial letter. ALSO READ: The cost of AI: Who pays to power the future? It then combines them to create a medically based analysis that residents can print and send back to their insurance company. Counterforce is free for anyone to use online. VIDEO: The cost of AI: Who pays to power the future?
Medscape
20 minutes ago
- Medscape
Alternative Funders and Costly Meds: Are Patients Insured?
In the ever-evolving landscape of employer self-funded healthcare, cost-saving strategies emerge with promises of efficiency and reduced spending. Yet, for real patients — especially those battling chronic illnesses such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease — these quick-fix schemes can have devastating, unintended consequences. Among the most disruptive of these strategies in employer-funded health plans is the involvement of alternative funders: third-party entities inserted between patients and their essential therapies. Real patient stories most powerfully illustrate the physical, emotional, and financial harm they experience. Self-Insured Employers and Alternative Funder Programs Rising healthcare costs have led many employers to seek new ways to manage the growing expenses of self-insured health plans. Strategies such as alternative funder programs (AFPs) have been touted as ways to keep costs down and preserve financial stability for businesses. While these methods might give some relief to employer balance sheets, they can cause medication access delays and disruption, as well as added complexity, confusion, and stress for the patient. Madelaine (Mattie) A. Feldman, MD Essentially, AFPs contract with the employer to stop all coverage of the cost of expensive medicines, which includes most, if not all, of the biologic drugs. The AFPs will then apply for patient assistance from manufacturers and other programs under the guise of the patient being 'uninsured.' If assistance is obtained (free drug or copay cards), they will charge the employer a percentage of the price of the drug or card. Most manufacturer assistance programs have put up guardrails to prevent what they consider to be abuse of programs meant to help the truly 'uninsured.' If AFPs are unable to obtain free drugs, then they may try to source the medicine from outside of the United States, which manufacturers say is illegal. All of this creates delays in processing with denials and disruption of care for those relying on these specialty drugs. Employees are told they need to sign up for these programs or they may be responsible for the entire price of their medication, which often scares them into signing up, potentially giving the AFP years of access to very personal data. The Patient's Ordeal: When Savings Come Before Care Janelle Zeihen was diagnosed with Crohn's disease on February 14, 2022. Her diagnosis was delayed because her symptoms were initially mistaken for complications from recent pelvic radiation for cancer. Once properly identified, her gastroenterologist started her on vedolizumab (Entyvio, Takeda) infusions every 8 weeks and daily prednisone. This stabilized her condition, allowing her to eventually taper off prednisone. In January 2024, Zeihen's employer, Bedrock Healthcare, changed health insurance plans. She was told that vedolizumab would be covered only if she switched to home infusions via CVS's Coram home infusion service. Her disease remained controlled, but by August of that year, complications began when she was told her treatments would no longer be covered. Additionally, her gastroenterologist told her that she had been billed over $80,000 per infusion by Coram for the three infusions she had so far received in 2024, totaling $250,000. (In comparison, Medicare rates are only about $6500 per infusion.) This is when Zeihen's bureaucratic nightmare began. A nurse at the gastrointestinal doctor's office had worked with a certain rheumatology office manager and patient advocate, Nilsa Cruz, on difficult approvals for her patients in the past. She contacted Cruz to see if she could help to unravel the situation and hopefully get coverage for Zeihen to resume infusions at the rheumatologist's office. Cruz had many questions. Why was Zeihen supposedly covered for home infusion and then not covered? Why was she billed for three infusions that had already taken place? Did she have insurance or didn't she? Cruz spent more than 60 hours over 3 weeks reviewing paperwork, contacting insurances and third-party administrators, and spending time with Zeihen on her employer's employee/patient portal. She discovered that while Zeihen's insurance card listed Anthem, the plan was actually managed by Leading Edge Administrators, with provider-administered drug coverage handed over to Payer Matrix, an alternative funder. Cruz said that is when her 'heart sank.' She knew AFPs disrupted patient care and 'abused' patient assistance programs, resulting in many patients losing total access to treatments. Cruz found out after speaking with Anthem that they had mistakenly approved the home infusions in January 2024, but they were not actually responsible for administering or covering any costs to the plan. The company that Anthem was using to manage Zeihen's insurance plan, Leading Edge, had itself hired the AFP Payer Matrix to manage provider-administered drug coverage. Payer Matrix instructed Zeihen's employer, Bedrock, to exclude expensive biologics like vedolizumab from coverage. A Payer Matrix representative asked Cruz to apply for assistance from vedolizumab's manufacturer, Takeda, but Cruz said that she was obligated to tell Takeda that Payer Matrix was involved. Takeda denied the patient assistance request, suspecting improper use of their program for insured patients. Payer Matrix's nurse suggested to Zeihen that she change her medication to one from a different manufacturer from whom they may be able to get free drug. Zeihen was shocked that this 'insurance nurse' was trying to treat her without input from her gastroenterologist and she refused to agree to that. Cruz then went to Zeihen's employer for help, but the employer never responded to appeals or letters of medical necessity. Federal and state legislators/regulators and the Department of Labor were all copied on the communication. By now, Zeihen was left with overdue bills and denied treatments and no clear path to continue her medically necessary care. After persistent advocacy from Cruz, including contacting all involved parties, Anthem — who was not responsible for the coverage — agreed to cover all the vedolizumab infusions that Zeihen had received thus far in 2024 through Coram home infusion, as well as the next two scheduled treatments at the rheumatologist's office until the end of the year. This intervention relieved Zeihen from the $250,000 debt and allowed her to complete her treatment for the year. Where is Zeihen now? She was forced to leave her employer-covered insurance because the AFP in the plan had left her uninsured for the treatment that had been covered previously. She signed up for an exchange insurance plan, but her employer refused to cover any of the new exchange policy premiums, which were higher than her previous cost share. Ultimately, this resulted in her having to leave the full-time position with her employer. She now works part time and even though she lost many of the benefits of full-time employment, her Crohn's disease treatments are covered and the flares of her disease have subsided. She's not sure if her disease is better controlled because she is now getting her treatments in a timely manner or the fact that the stress, fear, and confusion caused by the AFP in her employer's plan is now gone. Why Employers Should Beware While pitched as a quick fix, AFPs may actually undermine employer goals in the long run. The administrative chaos can result in delayed or denied care, higher absenteeism, lost productivity, and even legal challenges if employees are saddled with unexpected medical debt. In addition, employers have a fiduciary duty to employees to prevent these costly arrangements that can cause psychological harm to employees. Furthermore, these programs can expose employers to reputational risk as stories of harmed workers spread. Zeihen's journey is emblematic of a growing problem in employer health benefits. The lure of immediate savings from AFPs often comes at an unacceptable cost to both employees and the organizations that depend on them. This story also displays the need for advocates like Cruz. Her dedication to patients and their well-being is exemplified in her perseverance and tenacity in finding a way to help Zeihen get the care she needed. I wish there were more 'Nilsa Cruzs' in this world. At the Coalition of State Rheumatology Organizations, we are fortunate to have the actual Nilsa Cruz in this story as part of our Payer Issue Response Team (PIRT). PIRT reviews 'payer' problems that are sent to us by rheumatologists around the country, and we do what we can to help solve them. While we can't solve every payer problem there is, we are grateful to be able to help those patients whose problems we can solve.
CBS News
21 minutes ago
- CBS News
ChristianaCare opens new micro-hospital in Chester County, Pennsylvania, filling gap in health care
A new micro-hospital is opening soon in Chester County, Pennsylvania, bringing emergency medical care back to a community that's gone without it for years. ChristianaCare is launching three micro-hospitals in the Philadelphia region, starting with the first one in West Grove, which sits on the site of the former Jennersville Hospital. That facility shut down in 2021, leaving residents with long drives for emergency care. Kate Ramirez, director of nursing at ChristianaCare West Grove, is one of 90 staff members hired to run the new 20,000-square-foot facility. "I'm really excited," Ramirez said. "I'm local, like I said before, close to home. So we really needed something in this area." Micro-hospitals are smaller than traditional hospitals. Officials said West Grove is equipped to handle most emergencies, including strokes and heart attacks. Severe trauma, major surgery and STEMI heart attacks will require a different level of care, Dr. Vinay Maheshwari, physician executive for ChristianaCare, said. "We do not have an intensive care unit," Dr. Maheshwari said. "We do not have an operating room, so we don't have those types of capabilities, but we can manage the great majority of the conditions that are required from an emergency perspective." The West Grove micro-hospital offers advanced diagnostic tools, such as a CT scanner, and provides around-the-clock care. "Our hospital here has the capabilities for lab services that are not found in urgent care," James Bennett, Market CEO for ChristianaCare-Emerus, said. "We have board-certified emergency physicians 24/7." Before this, people had to drive 45 minutes away to Christiana Hospital in Newark or Chester County Hospital in West Chester for emergency care. For West Grove residents like Ray Moyer, the return of a local emergency facility brings peace of mind. "It makes me feel a lot more comfortable if I have an issue or if some of the neighbors have issues that there's a place close by for them to get immediate care," Moyer said. "At least they can stabilize you and then transport you. It's better than if you have a major issue having no nearby care. So I think it's a significant improvement." In addition to West Grove, ChristianaCare plans to open micro-hospitals in Springfield and Aston, both in Delaware County. The West Grove facility is expected to open in mid-August. In the meantime, signs have been posted outside letting the public know the hospital is not open yet, after some residents already showed up seeking services.
