logo
Eye care products recalled nationwide as customers warned to stop use ‘immediately'

Eye care products recalled nationwide as customers warned to stop use ‘immediately'

Yahoo12-05-2025

Nearly two million cartons of eyedrops have been recalled due to concerns about quality.
BRS Analytical Service, LLC announced the urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release.
The recall comes after a Food and Drug Administration (FDA) audit identified violations of Current Good Manufacturing Practice (CGMP).
CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
Although it's unclear what health risks may be posed, CGMP deviations could lead to 'unacceptable quality' of the recalled eyecare solutions, and it's 'not possible to rule out patient risks resulting from use of these products,' according to AvKARE.
The five solutions that have been recalled are Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution.
Eye solutions were shipped from May 26, 2023, until April 21, 2025. Consumers are being asked to fill out the 'Quantity to Return' section and the customer information block on the recall notice, which can be faxed or emailed to AvKARE. People are urged to submit the forms even if they don't have the recalled eyecare solutions anymore.
Consumers should throw away these products immediately or return them to the place of purchase to get a full refund. You can find a list of all the eyecare products that were a part of this recall here.
According to the FDA, the recall was also issued due to a 'lack of assurance of sterility' in these products. The recall affects more than 1.8 million cartons of eye drops.
On May 6, the recall was identified as a Class II one, which is 'a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,' according to the FDA.
The eyecare solutions are one of many everyday products that have been recalled in 2025. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon.
The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk.
In March, the FDA announced a recall of 1,068 bottles of Henkel's Tec Italy Totale Shampoo because they may contain the bacteria Klebsiella oxytoca, which can cause infections in the eyes, nose, and skin.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

3D Printing Technology Revolutionizes Breast Implants Industry - A $4.6 Billion Market by 2030
3D Printing Technology Revolutionizes Breast Implants Industry - A $4.6 Billion Market by 2030

Yahoo

timean hour ago

  • Yahoo

3D Printing Technology Revolutionizes Breast Implants Industry - A $4.6 Billion Market by 2030

Key players like Johnson & Johnson and Establishment Labs are driving innovation with FDA-approved products. Silicone implants lead the market due to their natural feel. North America dominates in market share, fueled by high awareness and cosmetic spending. Innovative trends like 3D printing are reshaping the industry. Breast Implants Market Dublin, June 06, 2025 (GLOBE NEWSWIRE) -- The "Breast Implants Market - Focused Insights 2025-2030" report has been added to Breast Implants Market was valued at USD 2.98 Billion in 2024, and is projected to reach USD 4.60 Billion by 2030, rising at a CAGR of 7.5%. The global breast implants market is set to grow due to the growing popularity of anatomical breast implants and generation-to-generation development in breast implants. KEY TAKEAWAYS By Product: The silicone breast implants segment holds the largest market share, as they are highly popular for offering a natural look and feel while maintaining shape even if ruptured. By Shape: The round shape segment shows the highest of 7.70%, as they are the most preferred breast implant shape category because they offer a fuller size across the breast area and limit the rotation of implants. By Surface: In 2024, the smooth surface segment accounted for the largest market share. Smooth surface breast implants are widely used for their natural feel and movement, enhancing effectiveness and reducing the need for repeat surgeries. By Application: The breast augmentation segment accounted for the largest market share. Breast augmentation is a top cosmetic surgery worldwide, with rising demand due to cosmetic and medical needs. By End-User: The cosmetology clinics segment holds the second largest market share of over 34%, driven by specialized, well-trained, well-experienced, and experienced plastic surgeons who regularly perform breast implant procedures in cosmetology clinics. By Geography: North America dominates the global breast implants market, with over 24% share. North America's breast implant market is growing steadily due to rising awareness, high beauty care spending, and interest in advanced procedures. BREAST IMPLANTS MARKET TRENDS & DRIVERS Rapid Development in Breast Implants with 3D Printing TechnologyThe breast implant industry is rapidly evolving with advancements in development and manufacturing technologies that create significant demand for breast implants. Of such one major development is the incorporation of 3D development technologies in the manufacturing and development of breast implants. It was started in the last decade when first-in-human clinical trials of 3D-printed breast implants (2019) were started in Germany, and now it is widespread across the global market. These 3D printing and development technologies offer the highest level of customization that attracts a significant consumer base. BellaSeno is one of the German companies that uses Evonik's Resomer polymer in its Senella breast implant (3D-printed) breast scaffold products. The polymer allows the scaffold to be absorbed in the body at a rate that matches the patient's Popularity of Anatomical Breast ImplantsRound shape breast implants are considered the gold standard for breast augmentation and reconstruction; however, in recent years, the development of anatomical implants has become an exciting trend in the industry. It involves the application of custom-molded implants that are designed and developed to mimic the shape and give a natural feel. Where anatomical breast implants become an ideal choice for women who are seeking to achieve a balanced look with a natural shape. Anatomical breast implants also known as tear-drop breast implants now commonly referred to as contour profile or shaped breast implants. These implants are filled with gel which gives a more natural feel and comfort making them the most popular choice among youngsters. These increasing applications in breast enlargement to breast implant exchange become popular for patients undergoing revision breast surgery, such as those patients who demand poly implant prostheses (PIP) implant Development in Breast ImplantsThe world of breast implants has witnessed significant and continued developments. Fourth and fifth-generation breast implants revolutionized the breast implant industry. In these generations, significant changes were noticed related to silicone gel cohesivity. In 4th and 5th generation breast implants, the shell of implants was further strengthened, and cohesive versions of silicone gel were used to significantly minimize complications related to gel leakage. In 5th-generation implants, they come up with highly form-stable gel that characterizes gummy bear implants. In addition, Establishment Lab - one of the key companies in the market came up with 6th generation breast implant. The company focused on a patient-centric approach in incorporating and developing revolutionary techniques in its Motiva product to enhance both safety and aesthetic outcomes- MOTIVA IMPLANTS. It is a first-of-their-kind feature that significantly revolutionizes the Volume of Breast Enhancement ProceduresWorldwide, with the widespread of cosmetology and medical aesthetic procedures, breast augmentation procedures become the second leading surgical cosmetic procedure. According to the International Society of Aesthetic Plastic Surgery (ISAPS) report 2024, more than 1.89 million breast augmentation procedures performed across the world contribute to significant demand for breast implants. Furthermore, the ISAPS article 2024 revealed that more than 4.1 million breast procedures were reported across the world. Of these, over 1.89 million surgical breast augmentation, around 903,266 breast lifts, approx. 686,000 breast reduction, and 335,939 breast implant removal procedures reported across the world. It indicates that the demand for breast surgeries is significantly high across the BREAST IMPLANTS MARKET SEGMENT INSIGHTS Key Market Segments Product: Silicone breast implants control the largest share, emphasizing their popularity for a natural appearance. Shape: Round shapes lead with a 7.70% growth rate, preferred for full-size enhancement and reduced implant rotation. Surface: Smooth surface implants dominate due to their natural feel and reduced need for replacements. Application: Breast augmentation claims the largest application share, fueled by rising cosmetic and medical demands. Geography: North America holds a dominant market share, driven by elevated awareness and advanced procedural needs. COMPETITIVE LANDSCAPEThe global breast implants market report consists of exclusive data on 13 vendors. AbbVie, Establishment Labs, Johnson & Johnson (MENTOR), GC Aesthetics, POLYTECH Health & Aesthetics, and Tiger Biosciences are among the leading companies holding a significant market share in the global breast implants market. These vendors offer high-quality and advanced breast implant solutions that meet customer demands and comply with regulatory standards. Major players are continuously enhancing the efficiency of their products and strengthening their market positions. They benefit from strong brand recognition and a broad geographical presence across global markets. Furthermore, the adoption of various strategic initiatives, such as product launches and the development of new products with advanced technologies and materials, has intensified market competition. By focusing on innovation and expanding their capabilities, these companies have successfully increased their revenue share and maintained a competitive edge in the breast implants Strategic Approaches to Strengthen Sales Ratios In 2025, Establishment Labs developed and launched Preserve, a minimally invasive breast tissue preserving technology for breast augmentation, mastopexy augmentation, and revision augmentation procedures. In 2024, the company established a manufacturing and corporate office in Costa Rica to increase the manufacturing capacity of breast implants and other products, which will create revenue growth opportunities. In 2024, Stratasys and CollPlant announced a collaboration to conduct a pre-clinical study for advanced and unique regenerative commercial-sized breast implants. With this collaboration, the companies reported that technology innovations will address around a $3 billion market opportunity in the future. In 2023, AbbVis' Allergen Aesthetics launched the Natrelle Campaign, which will promote and create awareness about the company's breast implant solutions with a higher level of customization. In 2023, Establishment Labs Holding announced the launch of Mia Femtech, a company that offers minimally invasive breast augmentation procedures in Japan to establish a new beginning in breast aesthetics. This expansion will deliver significant brand awareness about its breast implant solution in the Asian market. Key Vendors AbbVie Establishment Labs Johnson & Johnson (MENTOR) GC Aesthetics POLYTECH Health & Aesthetics Tiger Biosciences Other Prominent Vendors Bimini Health Tech Hans Biomed Guangzhou Wanhe Plastic Material Co., Ltd G.A.L.S. Private Limited Laboratoires Arion Sebbin Silimed Key Attributes: Report Attribute Details No. of Pages 136 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $2.98 Billion Forecasted Market Value (USD) by 2030 $4.6 Billion Compound Annual Growth Rate 7.5% Regions Covered Global Key Topics Covered: Chapter 1: Scope & Coverage: Breast Implants Market Overview Chapter 2: Breast Implants Market Premium Insights Key Highlights Regional Insights Chapter 3: Breast Implants Market Prospects & Opportunities Chapter 4: Breast Implants Market Industry Overview Projected Revenue of Breast Implants Market (2021-2030; $ Billions) Chapter 5: Breast Implants Market Segmentation Data Projected Revenue by Product (2021-2030; $ Billions) Silicone Saline Projected Revenue by Shape (2021-2030; $ Billions) Round Anatomical Projected Revenue by Surface (2021-2030; $ Billions) Smooth Textured Projected Revenue by Application (2021-2030; $ Billions) Breast Augmentation Breast Reconstruction Projected Revenue by End-user (2021-2030; $ Billions) Hospital Cosmetology Clinics Other End-user Chapter 6: Key Regions Overview Projected Revenue of Breast Implants Market (2021-2030; $ Billions) North America Europe Latin America APAC Middle East & Africa Chapter 7: Competitive Landscape of Breast Implants Market Competitive Landscape Key Vendor Profiles Other Prominent Vendors Key Strategic Recommendations For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Breast Implants Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio

New FDA-approved Alzheimer's blood test coming to Mayo Clinic
New FDA-approved Alzheimer's blood test coming to Mayo Clinic

Yahoo

timean hour ago

  • Yahoo

New FDA-approved Alzheimer's blood test coming to Mayo Clinic

The Brief The FDA has approved the marketing of a new blood test by Fujirebio. The biomarker test measures the ratio of tau and amyloid proteins in the blood of a person with symptoms of cognitive decline to confirm the presence of Alzheimer's disease. Mayo Clinic will be one of 37 Alzheimer's clinics across the country to receive the new blood testing equipment starting at the end of June. MINNEAPOLIS (FOX 9) - The U.S. Food and Drug Administration has approved the marketing of a new tool to that can test a person's blood to diagnose Alzheimer's disease. The blood test is a groundbreaking development to confirm the disease in patients who are already experiencing cognitive decline. What we know The diagnostic tool, called Lumipulse, is manufactured by the world-wide medical research and development firm Fujirebio. The procedure, called the G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test, measures the presence of the amyloid and tau proteins in the brain that build the plaques leading to Alzheimer's disease. Fujirebio will now start distributing the diagnostic tests by the end of June to 37 Alzheimer's clinics across the United States including Mayo Clinic in Rochester, Minnesota. "I was very excited to get the news that there was an FDA approved test," said Alicia Algeciras-Schimnich, Ph.D. of Mayo Clinic who's been offering a version of the blood test for the past year in their laboratory. "It's just increasing the access to patients, and now many more laboratories will be able to offer this test." Dr. Algeciras-Schimnich says Mayo hopes will have the capacity to offer 1,000 to 5,000 blood tests a month with this new diagnostic protocol. What patients say Tim Sandry admits he's never had the best memory, but when he approached turning 67, he and his wife Ellen started noticing changes. "I wanted to find out what's going on here," recalled Sandry when he and his wife decided to see a neurologist. The doctor put him through a series of cognitive tests and determined he had what's called mild cognitive impairment which is a noticeable slowing of memory function. It wasn't long after his cognitive tests that a new diagnostic spinal tap was available to detect the presence of Alzheimer's disease. But it was invasive and painful. "In the morning they took the spinal fluid, and then I had to stay very still for the rest of the day. And then they sent me home, and I had an awful headache for the next three days," said Sandry of the hospital procedure. This new test would have saved him the pain and provided reliable results. "Oh, so much difference," said Sandry about the chance to have had a diagnostic blood test. "I mean, this blood test is going to shake things up dramatically I believe." Why you should care The faster a person experiencing cognitive decline can get a positive diagnosis for Alzheimer's the faster they can start taking one of two recently FDA approved drugs to slow the progression of the disease. Those drugs are Leqembi and Kisunla. "It makes it much quicker for those people to start treatment and to start looking at what options there are, whether it's clinical trials or medication," said Jenna Fink of the Alzheimer's Association Minnesota-North Dakota chapter. Sandry has been on a regimen of Leqembi since his own diagnosis and he believes it has dramatically slowed the disease in his own brain. "The sooner you get diagnosed, the quicker you can get on those drugs and the less damage this will do to your brain And the longer you will be able to function, cognitively," he said. Dig deeper The new blood test not only speeds up the diagnosis process, it also offers more accuracy. "The clinical diagnosis of Alzheimer disease is only about 70-75% accurate," said Mayo's Alicia Algeciras-Schimnich of the standard practice of cognitive testing and PET scans of the brain. Adding the blood biomarker test increases the accuracy of an Alzheimer's diagnosis to 90-95%. "So really, it is a significant improvement in the diagnosis for patients, which now can have an earlier answer for their symptoms," said Algeciras-Schmnich.' By the numbers As many as 101,900 Minnesotan over the age of 65 are living with Alzheimer's according to the 2025 facts and figures report from the Alzheimer's Association. That adds up to 10.7% of Minnesota adults over 65. Alzheimer's affects more than just the patients. For every patient, there are caregivers, many of them family members. When those numbers are added up, the Alzheimer's Association estimates there are 166,000 caregivers in Minnesota. Across the nation, 7.2 million Americans are living with the Alzheimer's, and 74% are over the age of 75.

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)
YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)

Yahoo

time5 hours ago

  • Yahoo

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)

SHANGHAI, June 5, 2025 /PRNewswire/ -- YolTech Therapeutics, a clinical-stage biotechnology company developing in vivo genome editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for YOLT-101, an in vivo base editing therapy targeting PCSK9 for the treatment of heterozygous familial hypercholesterolemia (HeFH). "The FDA IND clearance marks a significant milestone for YolTech," said Dr. Yuxuan Wu, Co-founder and CEO of YolTech Therapeutics. "In vivo gene editing represents a new generation of therapeutics—offering one-time, durable solutions for chronic and genetic diseases. We are committed to advancing breakthrough gene editing solutions that offer transformative benefits for patients living with severe genetic and cardiovascular diseases. '' About YOLT-101 YOLT-101 is an investigational in vivo base editing therapy designed to be a single-dose treatment to durably reduce blood LDL-C. It is based on YolTech's proprietary adenine base editor, YolBE—specifically hpABE5—which comprises nCas and a novel deaminase evolved from Hafnia paralvei. For delivery, YOLT-101 utilizes YolTech's innovative lipid nanoparticle (LNP) delivery system. Unlike traditional CRISPR/Cas9 systems that rely on DNA double-strand breaks (DSBs), hpABE5 enables precise A•T to G•C base conversion without introducing DSBs, thereby significantly reducing risks of chromosomal abnormalities and off-target effects. YOLT-101 is being evaluated in ongoing investigator-initiated trial (IIT), where it has demonstrated a favorable safety profile and robust LDL-C–lowering effects. For detailed clinical data, please refer to: About Familial Hypercholesterolemia (FH) Familial hypercholesterolemia (FH) is caused by mutations in LDL metabolism-related genes such as LDLR, APOB, and PCSK9. Patients with FH exhibit significantly elevated levels of low-density lipoprotein cholesterol (LDL-C) and a high risk of early-onset atherosclerotic cardiovascular disease (ASCVD). The estimated global prevalence of FH is 1 in 200 to 1 in 250, affecting approximately 34 million individuals worldwide. Current treatment strategies—lifestyle modifications, statins, ezetimibe, PCSK9 inhibitors, lipoprotein apheresis, and even liver transplantation—often fall short in terms of efficacy, tolerability, or patient adherence. This creates a critical unmet need for durable, one-time therapies that can address the root cause of disease. About YolTech YolTech Therapeutics is a clinical-stage in vivo gene editing company committed to pioneering the next generation of precision genetic medicines. Our approach combines innovative gene editing technologies with an advanced lipid nanoparticle (LNP) delivery system, creating a versatile platform designed to address a wide range of serious diseases. Central to our mission is the development of internal capabilities, including end-to-end manufacturing, to ensure the highest standards of quality and scalability. Our lead candidate, targeting ATTR, marks a significant milestone as China's first LNP-mediated in vivo gene editing therapy to enter clinical development. With promising early clinical outcomes, YolTech is also advancing therapies for familial hypercholesterolemia (FH) and primary hyperoxaluria type 1 (PH1). As a company dedicated to transforming the treatment landscape, YolTech continues to push the boundaries of what is possible in gene editing. To learn more, please visit: View original content: SOURCE YolTech Therapeutics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store