Par Pharmaceutical, Inc.

Endo Pharmaceuticals' unit Endo USA has issued a voluntary recall of one lot of the anti-anxiety drug clonazepam. Endo USA, a unit of Endo Pharmaceuticals, issued a voluntary recall of one lot of clonazepam tablets due to a labeling issue that resulted in an incorrect strength being printed on the cartons. The recall affects 0.25 milligram tablets with labeling that wrongly indicates they were 0.125 milligrams in strength, the company said in a July 16 press release. Despite the error, the blister pack featured the correct strength description. The company said the error was due to a third-party packager. Clonazepam is typically used for acute treatment of panic disorder, epilepsy, and nonconvulsive status epilepticus. It is also used for off-label treatment of restless leg syndrome, acute mania, insomnia, and tardive dyskinesia. The recalled lot was packaged in cartons of 60 tablets with a National Drug Code (NDC) number 49884-307-02. The drugs were distributed nationwide through wholesale distributors to retail pharmacies, which are being asked to return any existing inventory they have. Endo warned that there is a “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 hasn’t received any reports of adverse events associated with the recall, the company said. The latest voluntary recall falls just four months after another Endo unit, Par Pharmaceutical, recalled one lot of its pulmonary arterial hypertension (PAH) drug treprostinil injection from the U.S. market over concerns that silicone particles could be in vials of the drug. Treprostinil is a generic to United Therapeutics’ Remodulin, which has been marketed for over 20 years. In February, the parent company Endo, agreed to pay a bankruptcy settlement worth up to $464.9 million to the federal government after a Department of Justice investigation into its previous marketing of opioid painkiller Opana ER.

Palani Palaniappan, Ph.D., Stephen Hoffman, M.D., Ph.D., and Paul Westberg, MBA, bring deep industry experience to guide Company growth COLUMBUS, Ohio--(BUSINESS WIRE)-- Clarametyx Biosciences Inc. (“Clarametyx”), a clinical stage biotechnology company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the appointment of Palani Palaniappan, Ph.D., to its Scientific Advisory Board, as well as the appointments of Stephen Hoffman, M.D., Ph.D. and Paul Westberg, MBA as strategic advisors. “We are humbled to welcome Dr. Palaniappan to our scientific advisory board, as his extensive industry knowledge will not only augment our scientific focus but introduce critical development expertise that will enable us to pursue the full potential for our novel anti-biofilm technology,” said David Richards, Chief Executive Officer. “We are also pleased to engage Stephen Hoffman, MD, Ph.D. and Paul Westberg, MBA, who will further enhance our corporate and strategic development activities as we build momentum toward the next phase of the company’s growth.” Palani Palaniappan is an experienced business leader passionate about developing innovative and impactful medicines for patients. He is currently Chief Technology Officer of Pioneering Medicines at Flagship Pioneering. Dr. Palaniappan previously served as the Executive Vice President and Chief Technology Officer at Aruvant Sciences. His prior executive roles included Head of Global Technical Operations at Sarepta Therapeutics and Global Head of Biologics and New Modality Development at Takeda Pharmaceuticals. His early career included leadership positions at Millennium Pharmaceuticals (acquired by Takeda), Biogen, Nexstar Pharmaceuticals (acquired by Gilead), and Par Pharmaceuticals. Palani received his Ph.D. from the Indian Institute of Technology, Kanpur and completed his post-doctoral studies in biochemistry and biophysics at the University of California, Riverside and Virginia Commonwealth University. He holds a M.S. and B.S. from Annamalai University. Stephen Hoffman is a seasoned life sciences executive with over 30 years of experience building companies and leading entrepreneurial teams to create shareholder value. He is currently a Managing Partner and Co-Founder of Trekk Venture Partners and serves on multiple public and private company boards. He was previously the CEO of Aerpio Pharmaceuticals, Inc. and Allos Therapuetics, Inc. and served as Managing Director at Skyline Ventures, as well as General Partner at TVM Capital. Paul Westberg is a strategic business executive with more than 25 years of broad transactions, financing, market planning, and advisory experience focused on advancing transformational therapies in the life sciences sector. He was most recently the Chief Business Officer of Qpex Biopharma, a resistance-focused infectious disease company, which was acquired by Shionogi. Earlier in his career, Mr. Westberg was Chief Business Officer at Versartis and has previously served in numerous business development and finance roles for start-up companies since starting his career at Genentech. Mr. Westberg received his MBA from the University of California, Berkeley and his BA from the University of California, San Diego. About Clarametyx Biosciences Clarametyx Biosciences is combating the formidable challenge of persistent and recalcitrant 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 dynamic pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections. For more information, visit us on the web or on LinkedIn.

DUBLIN, April 22, 2024 /PRNewswire/ -- Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is expanding its voluntary recall to include seven lots of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution. Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Par has not received any reports of adverse events related to this recall. Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration. Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. The following lots are affected by this recall: The lots were distributed nationwide to wholesalers and hospitals from June 16, 2022 through August 7, 2023. See labels of vials from the affected lots here. Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product. For information regarding the recall process, call Inmar, Inc. at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to the voluntary recall of Treprostinil Injection, the reasons for and the risks associated with the recall, the potential for adverse events and adverse event reporting, communications with and responses from regulators, 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 or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "outlook," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of risk factors. Additional information concerning risk factors can be found in press releases issued by the Company, as well as public periodic filings with the U.S. Securities and Exchange Commission (the "SEC") and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K. SOURCE Endo International plc