Artificial tears, other eye products recalled; consumers urged to discontinue use
Artificial tears, other eye products recalled; consumers urged to discontinue use
Over-the-counter ophthalmic products were voluntarily recalled due to a manufacturing deviation discovered during a U.S. Food and Drug Administration audit, a notice says.
Pharmaceutical distributor AvKARE was notified of the consumer level drug recall by the recalling firm, BRS Analytical Services LLC. The recall was issued for several products as a result of manufacturing deviations that "may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products."
The notice warns consumers to stop using the affected products immediately. AvKARE said the FDA is aware of the recall, and the health hazard linked to the items is unknown.
USA TODAY reached out to AvKARE for more information.
Car recalls: Volvo, Volkswagen, Polestar among over 500,000 vehicles recalled
When were the items distributed?
The recalled products were shipped from May 26, 2023, to April 21, 2025, AvKARE said.
Which products were voluntarily recalled?
AvKARE's press release includes a detailed chart with the lot numbers and expiration dates of the recalled products below. A recall notice posted on the FDA's website identified the amount of cases involved in the recall.
13,104 cases of Lubricant Eye Drops Solution; national drug code (NDC): 50268-126-15
32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution; national drug code (NDC): 50268-068-15
14,333 cases of Polyvinyl Alcohol Ophthalmic Solution; national drug code (NDC): 50268-678-15
1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1%; national drug code (NDC): 50268-066-15
13,872 cases of Artificial Tears Ophthalmic Solution; national drug code (NDC): 50268-043-15
What should consumers do?
Buyers who may have these recalled products in their inventory are urged to complete a downloadable PDF "Quality to Return" form attached to the recall notice and fax it to 931-292-6229 or email it to customerservice@avkare.com.
Then, the company will send the customer a "Return to Authorization Form" to ship the recalled product back to the listed address to get a full credit, including shipping costs.
Taylor Ardrey is a news reporter for USA TODAY. You can reach her at tardrey@gannett.com.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
4 hours ago
- Yahoo
XellSmart Secures FDA Clearance for Three Phase I INDs of Allogeneic iPSC-Derived Cell Therapies Targeting Major CNS Diseases: Parkinson's Diseases, Spinal Cord Injury and ALS
SUZHOU, China, June 2, 2025 /PRNewswire/ -- XellSmart Biomedical Co., Ltd. (Suzhou/Shanghai, China) is a leading biotechnology company dedicated to the development of innovative iPSC-derived cell therapies. To date, the company has received seven Investigational New Drug (IND) approvals for registered clinical trials from both the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA). All approvals focus on clinical-grade, off-the-shelf and allogeneic iPSC-derived cell therapy candidates targeting central nervous system (CNS) diseases with significant unmet medical needs, including: Parkinson's Disease (PD), the world's second most prevalent neurodegenerative disease affecting over 10 million patients globally (Phase I clinical trials in both China and the U.S.); Spinal Cord Injury (SCI), a major CNS disease impacting more than 10 million patients globally (First-in-Class; Phase I clinical trials in China and the U.S.); and Amyotrophic lateral sclerosis (ALS), a devastating rare neurodegenerative disease (First-in-Class; Phase I/II clinical trial in China and Phase I in the U.S.; designated as an Orphan Drug by the U.S. FDA). XellSmart has completed multiple cases of iPSC-derived dopaminergic neural progenitor cell therapy for patients with Parkinson's disease, including"the first case"in China. This clinical study was approved by the National Health Commission (NHC) of China. In the clinical study, clinical-grade iPSC-derived dopaminergic neural progenitor cells were transplanted into the putamen of the striatum in patients with moderate to advanced Parkinson's disease. With follow-up periods exceeding 12 months, no cell therapy-related adverse events have been observed. Multiple patients showed significant improvements in key efficacy indicators, including"on/off"time duration and MDS-UPDRS scores, as well as notable enhancements in non-motor symptoms. XellSmart is committed to developing clinical-grade, off-the-shelf allogeneic iPSC-derived cell therapies targeting central nervous system (CNS) diseases with no effective treatment options. XellSmart is at the forefront of advancing innovative iPSC-based therapies to address major and intractable CNS disorders:In 2023, China's first iPSC-derived cell therapy (XS228 injection), developed by XellSmart, was granted by FDA as Orphan Drug Designation (ODD) for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, China's first national-level registered clinical study of an iPSC-derived cell therapy for Parkinson's disease—also developed by XellSmart—was approved and initiated, including the first case treated in China. In 2024, the world's first national-level registered clinical study of a subtype-specific iPSC-derived neural progenitor cell therapy (XS228 injection) for ALS was approved. Multiple patients, including the world's first ALS case treated with this approach, received therapy with good safety profiles and preliminary data showing slowed disease progression. In 2025, China's first registrational Phase I clinical trial of an off-the-shelf allogeneic iPSC-derived dopaminergic neural progenitor cell therapy (XS411 injection) for Parkinson's disease was launched, led by the National Neurological Disease Medical Center at Beijing Tiantan Hospital. In 2025, China's first randomized, double-blind, controlled Phase I/II clinical trial of XS411 injection was initiated to treat early-onset Parkinson's disease (EOPD), led by Huashan Hospital of Fudan University, a National Neurological Disease Medical Center. In 2025, the world's first registrational Phase I clinical trial of an off-the-shelf, allogeneic iPSC-derived subtype-specific neural progenitor cell therapy was launched by The Third Affiliated Hospital of Sun Yat-sen University, targeting spinal cord injury (SCI) — a major neurological disorder with no effective treatment. In 2025, the world's first Phase I/II registrational clinical trial of XS228 injection—an off-the-shelf, allogeneic iPSC-derived subtype-specific neural progenitor cell therapy—was initiated by Peking University Third Hospital, targeting ALS, a devastating rare neurodegenerative disease. XellSmart has established a fully dedicated, internationally competitive "All-In" team focusing on development of clinical-grade, allogeneic, off-the-shelf iPSC-derived cell therapies for central nervous system (CNS) diseases that currently lack effective treatment options. XellSmart has built a portfolio of proprietary, globally leading industrial technologies and platforms, fueling sustained in-house innovation centered on its core business. To develop iPSC-derived cell therapy candidates, XellSmart has established and operates an R&D center, a B+ and A-grade GMP manufacturing facility, and a quality control center spanning over 5,000 square meters. Multiple clinical-grade iPSC-derived cell therapy candidates developed by XellSmart have completed core CMC development, with fully integrated clinical-grade manufacturing processes and quality control systems in place. XellSmart has successfully produced clinical batches of multiple GMP-grade iPSC-derived subtype-specific neural progenitor cell therapies, currently deployed in multiple clinical trials. XellSmart has secured multiple rounds of financing, collectively led by renowned market-driven venture capital firms including Qiming Venture Partners, Eli Lilly Asia Ventures, Sequoia Capital China (Hongshan), and others. View original content: SOURCE XellSmart Sign in to access your portfolio
Yahoo
7 hours ago
- Yahoo
Eupraxia Pharmaceuticals Announces Voting Results from Annual General and Special Meeting of Shareholders
VICTORIA, British Columbia, June 02, 2025 (GLOBE NEWSWIRE) -- Eupraxia Pharmaceuticals Inc. ('Eupraxia' or the 'Company') (TSX: EPRX) (NASDAQ: EPRX), a clinical-stage biotechnology company leveraging its proprietary DiffuSphere™ technology designed to optimize drug delivery for applications with significant unmet need, is pleased to announce the results from its Annual General and Special Meeting of Shareholders (the 'Meeting') held on June 2, 2025. Pursuant to a resolution passed by ballot vote, all of the six nominees proposed by management for election to the Company's board of directors (the 'Board') at the Meeting and listed in the Company's Management Information Circular dated April 25, 2025, were elected. The directors will remain in office until the next annual meeting of shareholders, or until their successors are elected or appointed. The results of the vote on the election of the Board are as follows: Board of Directors Votes in Favour Votes Withheld Number of Votes Percentage (%) Number of Votes Percentage (%) James A. Helliwell 17,880,699 99.997 505 0.003 Simon Pimstone 16,123,679 90.171 1,757,475 9.829 Richard M. Glickman 17,879,949 99.993 1,255 0.007 Paul Geyer 17,680,609 98.878 200,595 1.122 John Montalbano 17,876,501 99.974 4,703 0.026 Michael Wilmink 17,876,508 99.974 4,696 0.026 Joseph Freedman 17,880,699 99.997 505 0.003 The other items of business at the Meeting were to (i) re-appoint KPMG LLP as the auditor of the Company for the ensuing year and to authorize the Board to fix the remuneration of the auditors; (ii) approve the Company's 2025 Omnibus Incentive Plan; and (iii) approve the re-pricing of certain stock options previously granted to certain non-executive employees, none of which are insiders of the Company, under the Company's amended and restated stock option plan. All such items of business were passed by the shareholders at the Meeting. About Eupraxia Pharmaceuticals Inc. Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: Notice Regarding Forward-looking Statements and Information This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", 'suggests', "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes", "potential" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements in this news release include statements regarding the Company's product candidates, including their expected benefits to patients with respect to safety, tolerability, efficacy and duration; the results gathered from studies and trials of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; potential market opportunity for the Company's products, and potential pipeline indications. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy its our product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the potential impact of tariffs on the cost of the Company's API and clinical supplies of EP-104IAR and EP-104GI; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company's operations; the Company's restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company's common share price; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR+ ( and EDGAR ( Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise. For investor and media inquiries, please contact:Danielle Egan, Eupraxia Pharmaceuticals Inc.778.401.3302degan@ or Kevin Gardner, on behalf of:Eupraxia Pharmaceuticals Inc.617.283.2856kgardner@ SOURCE Eupraxia Pharmaceuticals in to access your portfolio
Yahoo
7 hours ago
- Yahoo
Minerva Biotechnologies - Overcoming the Solid Tumor Barrier: MUC1*-Targeted CAR T bearing 1XX mutations overcomes exhaustion and enables killing of low antigen expressing cancer cells
WALTHAM, Mass., June 02, 2025--(BUSINESS WIRE)--Minerva Biotechnologies published "Effective CAR T cell targeting of a MUC1 cleavage product" in the Journal for ImmunoTherapy of Cancer Novel target, MUC1*, is a cancer-specific growth factor receptor that is expressed on the surface of 75% of solid tumors. In this study, we compared the efficacy, persistence and antigen sensitivity of three MUC1* CARs, all directed to the tumor by the same antibody fragment, but bearing different co-stimulatory domains and one construct bearing the 1XX mutations in the CD3ζ cytoplasmic domain. We showed that in animal models, the MUC1* CAR-1XX increased CAR T-cell persistence and suppressed tumor recurrence by enabling the killing of low antigen-expressing cancer cells. "These findings in stringent animal models are very encouraging for developing 1XX CAR T cells to treat solid tumors," said Michel Sadelain, inventor of the 1XX technology. "They further underscore the promise of targeting the cleaved form of MUC1 known as MUC1*." The in vivo efficacy of MUC1* targeted CAR-1XX T cells against heterogeneous tumors comprising defined percentages of low vs high antigen expressing cancer cells predicts that a large patient population could be treated with MUC1* targeted CAR T immunotherapy. Although MUC1 has been known for 30 years to be aberrantly expressed in 75% of solid tumors, no therapeutic targeting MUC1 has ever been Food and Drug Administration approved. Part of the problem is that the identification of exactly which form of MUC1 drives tumor growth and metastasis has been controversial. The development of a MUC1* antibody that selectively recognizes the cancer-associated growth factor receptor form, as described here, is an important advance. Minerva has an FDA-approved IND for a MUC1*-CAR22 that persists longer in vivo enabling a more durable response in solid tumor treatment. We thank Memorial Sloan Kettering Cancer Center for the license to 1XX technology. View source version on Contacts Minerva Biotechnologies Ron Axelrod raxelrod@ 617-785-9491 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
