Trendvoyager Posted November 25 Posted November 25 A critical nationwide voluntary recall of the anxiety medication Clonazepam has been initiated by Pennsylvania-based Endo, Inc., following the discovery of a potentially dangerous labeling error. The recall, which began in July 2024 and was expanded in November 2024, specifically affects Clonazepam Orally Disintegrating Tablets. The issue arose when a third-party packaging company mislabeled cartons with inaccurate strength information and incorrect National Drug Code (NDC) numbers, posing serious risks for patients. This mislabeling has led to the recall of multiple lots of the medication, with the scope of the recall expanding from two lots in July to 16 lots by November. Consumers are urged to check their medication packaging against these lot numbers to ensure they are not affected. Sceenshot: FDA Clonazepam, marketed under the brand name Klonopin, is a potent benzodiazepine that acts on the central nervous system and is prescribed for anxiety disorders, seizures, and various neurological conditions. Taking incorrect doses could result in adverse effects such as pronounced sedation, confusion, dizziness, impaired reflexes, ataxia (loss of muscle coordination), and hypotonia (decreased muscle tone). These effects can pose significant dangers during daily activities like driving or operating machinery. Of even greater concern is the risk of life-threatening respiratory depression, particularly for individuals with existing pulmonary conditions, those taking maximum recommended doses, or patients using medications that could exacerbate respiratory effects. While Endo has reported no adverse events related to the mislabeled products as of the recall announcement, the company has implemented a comprehensive notification system to address the issue. Wholesalers, retailers, and consumers have been informed, and those in possession of the affected products are urged to consult their healthcare provider and return the medication to the original point of purchase for a full refund. To facilitate the recall process, Endo has partnered with Inmar, Inc., which is managing customer inquiries and product returns. Concerned individuals can contact Inmar at 855-589-1869 (Monday-Friday, 9 AM-5 PM ET) or via email at rxrecalls@inmar.com for assistance. This recall highlights the critical importance of accurate labeling in the pharmaceutical supply chain and the potential dangers even minor errors pose. The FDA and Endo are working closely to ensure patient safety and prevent future similar incidents. If you or someone you know is taking Clonazepam, it is strongly recommended to stay updated on this recall through your healthcare provider or the FDA’s website and to check your medication packaging against the recalled lot numbers immediately. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential https://www.today.com/health/recall/clonazepam-recall-rcna181340 https://www.foxnews.com/health/clonazepam-popular-anxiety-reducing-drug-recalled-nationwide-possibly-life-threatening-error Image: SoniPhotography | Dreamstime.com Quote
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