Clonazepam

MALVERN, Pa., Nov. 18, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) ("Endo") announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Continue Reading Carton front and blister pack Carton side Specifically, Endo's ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot. The following table details the lots being added to the voluntary recall, including lot product description and NDC number. Risk Statement: Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression. To date, Endo has not received any reports of adverse events associated with this product recall. Clonazepam Orally Disintegrating Tablets are indicated alone or as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder. Package Identification: The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed clonazepam before the product was acquired by Endo. The images below provide an example of the potential mislabeling showing the components of a package of Clonazepam Orally Disintegrating tablets, USP 2 mg lot 550176501 with a carton bearing the product description and NDC code of Clonazepam Orally Disintegrating Tablets, USP 1 mg 60-count. The location of the lot number on each component of the package is shown on the photographs within this release. Action Required: The product lots were distributed through wholesale distributors to retail pharmacies nationwide. Endo is providing written notification to wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory through Inmar, Inc. Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact Inmar on the below telephone line. Consumers in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product. In the event that a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician. Consumers with questions regarding this recall can contact Inmar by telephone at 855-589- 1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at [email protected]. For more information about Clonazepam Orally Disintegrating Tablets, USP, please see full Prescribing Information including BOXED WARNING available at DailyMed - CLONAZEPAM tablet, orally disintegrating (nih.gov). Adverse reactions or quality problems experienced with the use of this product lot may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program: Online: Mail: use postage-paid, pre-addressed Form FDA 3500 available at Fax: 1-800-FDA-0178 This product lot recall is being made with the FDA's knowledge. About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life- enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including but not limited to any statements related to product recalls, mislabeling, adverse events, FDA or other regulatory actions and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of risks, uncertainties and factors, including risks and uncertainties related to the recall and any future recalls, potential adverse events and any regulatory actions by the FDA. Endo assumes no obligation to publicly update any forward- looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with its Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Gardena's Premier Destination for Residential, In-Network Treatment GARDENA, Calif., Oct. 17, 2024 /PRNewswire/ -- The vibrant city of Gardena has welcomed an exciting addition to its wellness community with the grand opening of Clear Behavioral Health Residential Rehab Treatment Center. As Clear's 15th location within Los Angeles County, this comprehensive behavioral health facility will serve Gardena, the South Bay, and surrounding areas by providing a residential rehab and detox facility for addiction recovery and dual diagnosis treatment. Continue Reading Step inside Clear Behavioral Health's Residential Rehab Treatment Center in Gardena, CA. Serving Los Angeles County and surrounding areas by providing a residential rehab and detox facility for addiction recovery and dual diagnosis treatment. At this new 20 bed facility, clinicians treat a wide variety of substance use disorders and mental health conditions, including Alcohol/Opiate/Stimulant Use Disorder, Benzodiazepine dependence, dual diagnosis addiction w/ depression, anxiety, trauma, ADHD Staggering statistics forecast that only 28% of eligible Detox/Rehab/RTC individuals, and a mere 11% of eligible PHP/IOP individuals, will receive treatment in 2026. Clear's new facility aims to bridge that gap for those in need of care. The new location expands Clear's treatment capacity by 20 beds, enabling more individuals to receive comprehensive, evidence-based treatment that most major insurance providers cover. At this new Gardena facility, clinicians treat a wide variety of substance use disorders and mental health conditions, including Alcohol Use Disorder, Opiate Use Disorder (heroin, fentanyl, kratom, pain killers), Stimulant Use Disorder (methamphetamine, Adderall, crack/cocaine), Benzodiazepine dependence (Xanax, Klonopin), dual diagnosis disorders including addiction with depression, anxiety, trauma, ADHD, and other mental health diagnoses. Our highly individualized treatment plans are tailored to meet each client's needs at every step of their recovery journey. Dr. Martha B. Koo, MD, Chief Medical Officer and Clinical Supervisor of Clear Behavioral Health, brings unparalleled expertise and passion to addressing mental health solutions through Clear's services. Dr. Koo obtained her psychiatry residency training at the Resnick Neuropsychiatric Institute at UCLA and her subsequent psychoanalytic training at the New Center for Psychoanalysis. She is double Board-Certified in Psychiatry and Addiction Medicine and has over twenty years of psychiatric experience. "Our services at Clear Behavioral Health are designed to be highly individualized, evidence-based, and holistic, ensuring that each client receives care tailored to their unique needs," said Dr. Martha Koo. "We believe in treating the whole person—addressing not just the symptoms of mental health and addiction disorders but also the underlying issues. Our compassionate and experienced staff create a warm, welcoming environment that fosters healing and recovery, empowering individuals to reclaim their lives." Joining Dr. Koo's team as the Clinical Director of Clear's Substance Use Disorder Division is Jason Bernstein, LMFT. Jason holds a master's degree in clinical psychology from Antioch University. With over five years of experience in the substance use and mental health field, he is passionate about supporting individuals seeking dual diagnosis treatment on their journey toward healing, growth, and achieving emotional and psychological wellbeing. His commitment to providing compassionate care and fostering an environment conducive to recovery positions him as a valuable leader for the Gardena facility. "Our inpatient rehab provides the safety and comfort needed for individuals to detox and rehabilitate from addiction while also addressing underlying mental health disorders," said Jason Bernstein. "We are excited to welcome our first clients to Gardena, where we're proud to provide whole-person family-centered care. Every person deserves the opportunity to recover, grow, and live a functional, happy life." The Gardena facility features a home-like, safe, and clinical environment. Program Director Jamie Arthur, CATC, CADC-II, has over 10 years of experience in the substance use recovery field and is dedicated to ensuring clients receive a robust range of program services to launch their recovery. Services include: Round-the-Clock Clinical Staff: Our compassionate team led by Jason Giles, MD, and Brittany Skinner, PMHNP provides 24/7 supervised care. Peer Support: Group therapy sessions foster a sense of unity while providing the space to develop healthy relationships. Medication Management: Safe transitions into detox help patients regain mental and physical stability as comfortably as possible. Therapy and Counseling: Individual therapy and counseling help patients uncover the root of their mental health struggles and develop tools to regain self-trust and balance. Experiential Therapies: Group therapeutic wellness activities such as yoga, meditation and sound healing enhance recovery. In addition to the Gardena launch, Clear Behavioral Health has recently opened facilities in Van Nuys and El Segundo, providing outpatient mental health treatments for adults and teens. These locations offer Intensive Outpatient Programs (IOP), including individual therapy, peer support, holistic therapies, and academic counseling. Founded in 2015, Clear Behavioral Health is a subsidiary of Your Behavioral Health, a leading regional provider of mental health and addiction treatment services for adults and teens, with 28 facilities and growing throughout Southern California. Your Behavioral Health provides the full continuum of behavioral health care, including detox, outpatient (PHP/IOP), interventional psychiatry, and residential care across its family of brands — which includes Clear Behavioral Health, New Life House, and Neuro Wellness Spa — and delivers specialized programs for depression, anxiety, trauma-related issues, addiction and other mental health conditions. Co-founders Mike Joly, Chief Executive Officer, and Dr. Martha Koo, Chief Medical Officer, lead Your Behavioral Health alongside an expert team of clinicians across Southern California. For more information about Clear Behavioral Health or to schedule a free consultation, please visit our website at or call us at 877-564-5571. About Clear Behavioral Health ClClear Behavioral Health, formerly Clear Recovery Center, is a leading Los Angeles-based provider of comprehensive, in-network behavioral health treatment programs. Our mission is simple: to help those struggling with mental health and addiction live healthy and purposeful lives. Our unique story started with a vision to make clinically excellent, highly individualized mental health services accessible to all. For a list of our 15 locations, visit . About Your Behavioral Health Your Behavioral Health is a leading regional behavioral health services platform providing comprehensive, best-in-class services for adults and teens across the continuum of mental health and addiction treatment. With state-of-the-art facilities across Southern California, expert clinical teams, and a pioneering evidence-based approach, Your Behavioral Health offers specialized residential, inpatient, and outpatient programs for a range of mental health conditions. Its family of brands includes Clear Behavioral Health, New Life House, and Neuro Wellness Spa. For more information, please visit . Contact: Stephanie Paz Townsend (310) 295-0429 [email protected] SOURCE Clear Behavioral Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED