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Coca-Cola Recalls Over 10,000 Cans of Coke—Here's What to Know

Coca-Cola Recalls Over 10,000 Cans of Coke—Here's What to Know

Yahoo25-03-2025

When food and beverages are mass produced as they are in our modern world, there is always going to be a small percentage of unwanted contaminants and hazardous risks that slip through the cracks. Whether it's the discovery of the presence of a foreign material, faulty packaging or a simple mislabeling event, recalls are an unavoidable byproduct of the business.
This year, product recalls have seemingly been off the charts, with Coca-Cola now joining the fold with a recall of its own. On March 6, a manufacturer of the famed soda giant issued a recall of over 10,000 cans of Original Coca-Cola due to the presence of plastic. Now, just a couple of short weeks later, the US Food & Drug Administration (FDA) officially upgraded the event to a Class II recall, citing the potential for 'temporary' or 'reversible' health consequences.
The FDA defines a Class II recall as the second-most severe risk level a recall event can receive. This indicates a situation in which 'the 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.'
In total, the recall names 864 12-packs of 12-ounce Original Coca-Cola cans that were manufactured by Reyes Coca-Cola Bottling, LLC in Milwaukee, Wisconsin. The silver lining here is that only a specific batch of 12-ounce cans are impacted by this recall, of which were distributed in both Illinois and Wisconsin.
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Those who wish to determine whether or not they have the recalled cans in their possession can look out for the following information printed on either the can or the box the cans were packaged in:
Can UPC: 0 49000-00634 6
Pack UPC: UPC 0 49000-02890 4
Date Code: SEP2925MDA
Time Stamp: 1100-1253
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In addition to the identifying information printed above, consumers can also look out for the following statement to be printed on the cans as well: 'Canned Under Authority of the Coca-Cola Company, Atlanta, GA 30313.'
While no other Coca-Cola products have been named in the recall as of now, it is important to note that since the recall was initiated in early March, chances are that the majority of affected products have already been pulled from retail shelves. In case you happen to have some of the recalled cans in your possession, however, it is recommended that you do not consume it, and rather throw it away or return to the original place of purchase for a full refund.
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Jaguar Health Provides Update on Meeting with FDA Discussing Statistically Significant Results of Responder Analysis of Breast Cancer Patients in Phase 3 OnTarget Trial and Potential Approval Pathway for Crofelemer
Jaguar Health Provides Update on Meeting with FDA Discussing Statistically Significant Results of Responder Analysis of Breast Cancer Patients in Phase 3 OnTarget Trial and Potential Approval Pathway for Crofelemer

Miami Herald

time3 hours ago

  • Miami Herald

Jaguar Health Provides Update on Meeting with FDA Discussing Statistically Significant Results of Responder Analysis of Breast Cancer Patients in Phase 3 OnTarget Trial and Potential Approval Pathway for Crofelemer

Productive and collaborative discussion on proposed pathway by the company to bring crofelemer to approval for cancer therapy-related diarrhea (CTD) in patients with metastatic breast cancer receiving selected targeted therapies The currently estimated US metastatic breast cancer population would qualify as an orphan population, which aligns with company's core focus on orphan diseases Company plans to promptly pursue authorization to initiate expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer SAN FRANCISCO, CA / ACCESS Newswire / June 9, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided a recap on the company's assessment of the in-person Type C Meeting on May 28, 2025 with the Division of Gastroenterology of the U.S. Food and Drug Administration (FDA) to discuss the statistically significant responder analysis results for adult patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial. "We were very happy to take part in the face-to-face Type C Meeting, the catalyst for which was the positive data in the subpopulation of breast cancer patients from our OnTarget trial," said Lisa Conte, Jaguar's founder, president, and CEO. "Napo proposed two simultaneous potential pathways during the meeting for making crofelemer available to metastatic breast cancer patients with the significant unmet medical need of CTD: conducting a pivotal treatment trial to facilitate approval of crofelemer for CTD in this focused patient population; and the prompt pursuit of authorization to initiate an expanded access program for breast cancer patients with CTD who may not be eligible for this study, including breast cancer patients in the adjuvant and neoadjuvant settings. We are pleased with the constructive and productive discussion that took place with the FDA during the meeting. Last week the FDA formally acknowledged both of these key discussion points in correspondence to Napo. We plan to submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer." Patient advocates participated in the Type C Meeting to share their raw and personal experience with CTD, including a metastatic breast cancer patient with uncontrollable diarrhea who received a prescription for crofelemer. "The design of the protocol for OnTarget was based on a survey of cancer patients. Today there are close to 100 approved targeted cancer agents. Thanks to these amazing drugs, metastatic cancer patients are living longer, frequently rendering cancer, and CTD, chronic ailments with which to live. To deepen our understanding of the current population of metastatic cancer breast with CTD, and ensure the clinical meaningfulness of the design of the anticipated pivotal treatment trial, we plan to conduct a new survey of this cancer patient population," Conte said. The currently estimated US metastatic breast cancer population potentially qualifies as an orphan population, in alignment with the company's core focus on orphan diseases. The company therefore intends to request orphan drug designation from the FDA for the CTD indication in this population. Given crofelemer's novel and paradigm-shifting mechanism of action, the company also plans to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory approval in the US for crofelemer for CTD in metastatic breast cancer patients. "Embracing a sharp strategic focus on orphan indications seems to fit with the new administration's efforts and philosophy," said Conte. "Dr. Marty Makary, the new Commissioner of the FDA, commented in April 2025 that the agency will open a new regulatory pathway based on what he called a 'plausible mechanism,' focusing mainly on rare or incurable diseases." As expressed during the Type C Meeting, the data from the first-of-its-kind prophylactic OnTarget study is invaluable, providing new insights into the natural history of the important and debilitating side effect of CTD. Diarrhea is a common side effect of targeted cancer therapies and can lead to dose changes, treatment delays, and often cessation of lifesaving cancer therapy. The benefit to risk ratio of crofelemer is well-documented, as the active agent has been commercialized for the approved indication of HIV-related diarrhea since 2012, with no crofelemer-related reported serious adverse events. In both the US and European Union, crofelemer has been granted orphan drug designation for the orphan diseases of short bowel syndrome with intestinal failure and microvillus inclusion disease. Crofelemer has been granted orphan drug designation for treatment of diarrhea in cholera in the US, where cholera is an orphan disease. Orphan drug designation in the US qualifies the sponsor of a drug for various development incentives, including tax credits for qualified clinical testing and relief of filing fees. Additionally, orphan drug designation in the US provides a seven-year period of marketing exclusivity to the first sponsor who obtains marketing approval for the designated orphan drug. While the multicenter, double-blind, placebo-controlled OnTarget pivotal trial did not meet its primary endpoint, the subgroup of adult breast cancer patients achieved statistically significant results in the responder analysis. In the responder analysis of patients with breast cancer on targeted therapies, crofelemer CTD prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial of crofelemer for diarrhea in adults with 10 solid tumor types receiving targeted therapy with or without standard chemotherapy. The OnTarget results in breast cancer patients were the subject of a poster presentation on December 11, 2024, at the San Antonio Breast Cancer Symposium, and additional significant results in adult breast cancer patients from the OnTarget study have been accepted for presentation as an oral rapid e-poster at the Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting in June 2025 in Seattle, Washington. About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. 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These include statements regarding Jaguar's expectation that the currently estimated US metastatic breast cancer population qualifies as an orphan population, Jaguar's expectation that the company will submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer, Jaguar's expectation that it will promptly pursue authorization to initiate an expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer patients, and that the expanded access program would potentially include breast cancer patients in the adjuvant and neoadjuvant settings, Jaguar's expectation that Napo will conduct a clinical trial of crofelemer for treatment of CTD in patients with metastatic breast cancer, Jaguar's plans to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory approval in the US for crofelemer for CTD in metastatic breast cancer patients, and Jaguar's expectation that additional significant results in adult breast cancer patients from the OnTarget study will be presented at the 2025 MASCC Annual Meeting. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc.

REMINDER: Jaguar Health to Conduct Fireside Chat 9AM ET June 10 as Part of Lytham Partners' Spring 2025 Spotlight Series
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Click here to register Discussion will focus on company's May 2025 meeting with the FDA to review the statistically significant responder analysis results for the subgroup of breast cancer patients in company's recently conducted Phase 3 OnTarget trial The currently estimated US metastatic breast cancer population potentially qualifies as an orphan population, in alignment with company's core focus on orphan diseases Company plans to promptly pursue authorization to initiate expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / June 9, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today issued a reminder that Lisa Conte, the company's founder, president and CEO, will participate in a virtual fireside chat at 9:00 AM Eastern tomorrow, Tuesday, June 10, 2025, as part of Lytham Partners' spring 2025 Spotlight Series. Participation Instructions for Jaguar Health's Virtual Fireside Chat During Lytham Partners Spring 2025 Spotlight Series When: Tuesday, June 10, 2025 from 9:00 - 10:00 AM Eastern Where: Online (Click Here). The fireside chat will also be available for replay following the event. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will participate in a virtual fireside chat June 10, 2025 as part of Lytham Partners' spring 2025 Spotlight Series, Jaguar's expectation that the currently estimated US metastatic breast cancer population may qualify as an orphan population, and Jaguar's expectation that it will promptly pursue authorization to initiate an expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer patients. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Source: Jaguar Health, Inc. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc.

U.S. Court of Appeals for the Federal Circuit Affirms Prior Delaware District Court Rulings in Favor of Acadia in NUPLAZID® (pimavanserin) Composition of Matter Patent
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Yahoo

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U.S. Court of Appeals for the Federal Circuit Affirms Prior Delaware District Court Rulings in Favor of Acadia in NUPLAZID® (pimavanserin) Composition of Matter Patent

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About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential," "continue" and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) the impact of the court ruling on our business and our ability to defend ourselves in the future; (ii) the continued patent protection for NUPLAZID; and (iii) the anticipated timing for termination of such protections. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our ability to maintain, protect and enhance our intellectual property; the outcome of other existing and potential future lawsuits challenging our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-Q for the quarter ended March 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law. View source version on Contacts Investor Contacts: Acadia Pharmaceuticals Kildani(858) 261-2872ir@ Acadia Pharmaceuticals Tieszen(858) 261-2950ir@ Media Contact: Acadia Pharmaceuticals Kazenelson(818) 395-3043media@ 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

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