Latest news with #Pseudomonasaeruginosa
Newsweek
2 days ago
- Health
- Newsweek
Coca-Cola Recall Update as FDA Issues Risk Warning for Contaminated Drink
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration (FDA) has assigned its second most serious risk level, Class II, to a recall of Topo Chico mineral water, owned by The Coca-Cola Company, following the identification of potential contamination with Pseudomonas bacteria. Newsweek reached out to The Coca-Cola Company, which issued the recall, via email for comment outside of regular working hours. Why It Matters The FDA categorizes its recalls from Class I through to Class III. A Class II recall refers to instances when "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences" or if the chance of "adverse health consequences is remote." Pseudomonas is a common group of bacteria. Pseudomonas aeruginosa is the type that most commonly causes infections, and patients in health care settings are the most vulnerable, including those on ventilators, those with catheters and those with open wounds, according to guidance from the U.S. Centers for Disease Control and Prevention (CDC). Stock image of a person holding a glass of sparkling water. Stock image of a person holding a glass of sparkling water. Getty Images What To Know The recall began on May 28, 2025, and was initiated by The Coca-Cola Company. The FDA issued the Class II risk classification on June 17, 2025. The recall was issued due to the potential presence of Pseudomonas in the mineral water. According to the FDA's release, "The firm was notified by their distributor that product placed on hold was released and shipped to customers." The recall involved 241 cases of Topo Chico Mineral Water Carbonated 16.9 fl oz (500 ml) bottles. The products can be identified by the following details: UPC: 0 21136 18061 9 (bottle), 0 21136 18062 6 (case) Lot Numbers: 11 A 2543, 12 A 2543, and 13 A 2541 Manufactured in Mexico by CIA. TOPO CHICO, S. DE R.L. DE C.V., Monterrey The affected bottles of Topo Chico were shipped to five states: Arizona, Louisiana, New Mexico, Nevada, and Texas. Coca-Cola has owned the sparkling mineral water brand Top Chico since 2017. The beverage giant owns a significant number of brands, including Sprite, Fanta, Smartwater and Powerade. What People Are Saying The Centers for Disease Control and Prevention's guidance on Pseudomonas aeruginosa reads: "Pseudomonas is a group of bacteria commonly found in the environment, like in soil and water. The most common type causing infections among humans is Pseudomonas aeruginosa. P. aeruginosa can cause infections in the blood, lungs (pneumonia), urinary tract, or other parts of the body after surgery." What Happens Next The recall is ongoing.
Business Wire
2 days ago
- Business
- Business Wire
PHAXIAM Therapeutics Announces the Suspension of Trading in Its Shares Until Delisting
LYON, France--(BUSINESS WIRE)--Regulatory News: PHAXIAM Therapeutics (Euronext: PHXM - FR001400K4B1), hereinafter referred to as 'the Company' or 'PHAXIAM,' a biopharmaceutical company specializing in the development of innovative treatments for resistant bacterial infections, asked Euronext to suspend trading of its shares listed on the Euronext Paris market starting today, Wednesday, June 18, 2025, before the market opens. Trading in PHAXIAM shares (FR001400K4B1) will remain suspended until the completion of the delisting procedure for PHAXIAM shares, which will take place shortly, following a request made to Euronext. As previously announced, no reimbursement will be made to shareholders. About PHAXIAM Therapeutics PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacteria-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR001400K4B1, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit
Business Wire
4 days ago
- Health
- Business Wire
Clarametyx Biosciences Announces Positive Interim Analysis in Phase 2A Study Evaluating CMTX-101 for Infections Associated With Cystic Fibrosis
COLUMBUS, Ohio--(BUSINESS WIRE)-- Clarametyx Biosciences, Inc. ('Clarametyx'), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory diseases, announced today that it is advancing a Phase 1b/2a clinical trial evaluating its novel immune-enabling antibody therapy CMTX-101 to treat cystic fibrosis (CF)-associated pulmonary infections, based on the DMC's approval to proceed following results of a pre-specified interim analysis. 'Interim findings from this study have identified encouraging trends that support the potential benefit of CMTX-101, with no safety issues,' said Jerry Nick, MD, Professor in the Division of Pulmonary, Critical Care and Sleep Medicine at National Jewish Health, and primary investigator of the study. 'The next portion of the trial will provide important insights on the potential therapeutic impact of CMTX-101 for the CF population as a novel solution to reduce the burden of chronic infections.' The ongoing randomized, double-blind, placebo-controlled clinical trial is assessing CMTX-101 as an adjunctive therapy to standard of care antibiotics in people with CF, evaluating safety and tolerability, pharmacokinetics, immunogenicity, reduction of pulmonary Pseudomonas aeruginosa burden, and additional exploratory endpoints. An interim analysis of data from the first 21 participants enrolled met the pre-specified criteria to continue the trial at both 5 and 30 mg/kg dose levels. Participants treated with CMTX-101 demonstrated a reduction in P. aeruginosa burden based on prespecified statistical criteria and CMTX-101 was shown to be present in the sputum of all treated participants. Importantly, CMTX-101 was generally well tolerated, consistent with the findings reported in a prior clinical study, and no antidrug antibodies were detected. The upcoming portion of the study will continue evaluating both doses of CMTX-101 versus placebo among approximately 20 additional participants from 23 study sites, including significant support from the Cystic Fibrosis Therapeutics Development Network. Study enrollment is expected to be complete by the end of 2025. More information on the study and participating sites is available at ( using the identifier NCT06159725. 'We are pleased that the findings from the first 21 participants enrolled support progressing the study without modification. The full dataset, which will include exploratory endpoints such as respiratory function, inflammatory biomarkers and quality of life assessments, will help us further understand the full potential of CMTX-101 as a novel therapeutic solution to a variety of chronic respiratory conditions,' said David V. Richards, Chief Executive Officer, Clarametyx. 'We extend our gratitude to the Cystic Fibrosis Therapeutics Development Network, clinical investigators, and the participants and families for their continued participation in this important research.' About CMTX-101 CMTX-101 is an investigational immune-enabling antibody therapy in development to treat chronic and recalcitrant respiratory infections. The therapy is designed to precisely and rapidly destroy the universal underlying structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective antibiotic and immune intervention. Because the target is universally present across bacteria, the approach can be employed to treat a range of bacterial infections and pathogen types. The goal of treatment is to dramatically improve the effectiveness of antibiotic therapies and innate immune system effectors, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics. It is currently in development to treat cystic fibrosis-associated infections, with opportunities to expand to other chronic respiratory infections including nontuberculous mycobacterial (NTM) lung disease, non-CF bronchiectasis (NCFB), and chronic obstructive pulmonary disease (COPD). About Clarametyx Biosciences Clarametyx Biosciences is combating the formidable challenge of chronic, recalcitrant respiratory infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response and antibiotic intervention. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines, including CMTX-101, which is in a Phase 2 study for infections associated with cystic fibrosis, and CMTX-301, which is in early development. For more information, visit us on the web or on LinkedIn.
Business Wire
12-06-2025
- Business
- Business Wire
PHAXIAM Therapeutics Announces Judicial Liquidation and Delisting
LYON, France--(BUSINESS WIRE)--Regulatory News: PHAXIAM Therapeutics (Euronext: PHXM - FR001400K4B1), hereinafter referred to as 'the Company' or 'PHAXIAM,' a biopharmaceutical company specializing in the development of innovative treatments for resistant bacterial infections, today announces that the Lyon Commercial Court has ordered the judicial liquidation (liquidation judiciaire) of the Company on June 11, 2025. As part of the judicial receivership proceedings (redressement judiciaire), two offers were submitted but were unable to result in the acquisition of PHAXIAM's assets. The Lyon Commercial Court has appointed Maître Pierre Martin as liquidator. Following this decision, PHAXIAM Therapeutics will request the delisting of its shares from Euronext, as previously announced. PHAXIAM reiterates that no reimbursement to shareholders can be made. Despite the efforts undertaken by the Company and its management to extend its financing horizon and maintain its operations, extremely challenging market conditions—particularly for small-cap listed biotech companies—did not allow for the implementation of a viable refinancing solution, leading the Company to file for receivership in early March 2025. Since 2017, PHAXIAM has provided more than 140 patients with phage-based treatments produced under pharmaceutical-grade standards, within a compassionate use framework. The Company sincerely hopes that these patients will continue to receive appropriate medical care and support despite the cessation of its activities. PHAXIAM would like to express its deep gratitude to all its stakeholders – including employees, partners, healthcare professionals, and shareholders – for their dedication and support throughout its journey. About PHAXIAM Therapeutics PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacteria-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR001400K4B1, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
Yahoo
09-06-2025
- Health
- Yahoo
Dr Pepper recall upgraded over serious health risk
A recall on cases of Dr Pepper has been upgraded due to a serious health risk. On May 23, the United States Food and Drug Administration (FDA) and Dr Pepper issued a voluntary recall on 19,203 12-pack and 24-pack cases of 12-ounce cans of Dr Pepper Zero Sugar. Then, on Thursday, the FDA's recall was upgraded to Class II, which the organization describes as a 'situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.' Although the cans, produced by Jacksonville, Florida-based Pepsi Beverages Company, were labeled 'zero sugar,' they were found to contain the full amount of sugar that is in a regular can, which is around 39 grams. The recalled cans have the product code XXXXRS05165 with a 'best by' date of February 16, 2026. The soda was only distributed to retailers in Florida, Georgia, and South Carolina. The recall only applies to Dr Pepper Zero Sugar and not any other Dr Pepper products. Customers who have purchased the affected Dr Pepper cans are urged to return the product to where they were purchased in exchange for a full refund or to throw them away. A mislabel like this can lead to issues for anyone who needs to avoid sugar, or for diabetics who need to strictly monitor their sugar intake. If a person with diabetes eats too much sugar, it can lead to hyperglycemia, which is a condition where blood sugar levels become dangerously high, resulting in symptoms such as increased thirst and blurred vision. According to the Cleveland Clinic, if hyperglycemia is left untreated, it can develop into diabetes-related ketoacidosis (DKA), which can be fatal. The upgraded recall comes after Coca-Cola sent a letter to Costco members last week announcing that they were voluntarily recalling Topo Chico Mineral Water due to the possible presence of Pseudomonas aeruginosa, a bacteria that occurs naturally in water sources, including mineral water. According to the letter sent to customers, the health risks of consuming mineral water with Pseudomonas are 'very low' in healthy individuals and will only cause 'minor health consequences' in people with 'weakened immune systems.' 'The safety and quality of the products we offer our consumers is our top priority,' the letter read. The recall specifically applies to bottles that were sold at select Costco warehouses in Texas and Louisiana from May 20 to May 29, 2025. The water bottles were sold in 18-packs and have the lot number 13A2541 printed on both the case's packaging and the neck of the individual bottles. Customers who have purchased the affected water bottles are urged to return them to their local Costco in exchange for a full refund. Any questions regarding the recall can be directed to Coca-Cola using the phone number 1-800-GET-COKE.
