The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of 16 lots of Clonazepam Orally Disintegrating Tablets due to a serious labeling error that could lead to life-threatening consequences if incorrect dosages are taken. The recall was initiated by pharmaceutical company Endo Inc., which cited a third-party packaging error as the source of the mislabeling.
Clonazepam, commonly prescribed to manage anxiety and seizure disorders, was found to have packaging that incorrectly displayed dosage strength and included an inaccurate National Drug Code (NDC). These errors could result in patients consuming an incorrect dose, potentially leading to severe health risks, particularly in sensitive populations such as children and individuals with pre-existing conditions.
The FDA has emphasized the gravity of the situation, warning that the incorrect dosages could cause “life-threatening” side effects. Despite the seriousness of the error, Endo Inc. confirmed that no adverse effects related to the mislabeled products have been reported as of November 21, 2024.
Consumers who have the affected lots are advised to stop using the product immediately and consult their healthcare provider for guidance. Retailers and distributors have also been instructed to halt the sale and distribution of the impacted lots and return them to their point of purchase or contact Inmar, the company managing the recall logistics.
Affected consumers can check the specific lot numbers on the FDA website or consult their pharmacist to determine if their medication is part of the recall. Any unused tablets from the recalled batches should not be consumed or disposed of without proper guidance.
Patients concerned about taking an incorrect dose are urged to seek medical advice promptly. For questions about the recall or to facilitate product returns, individuals can contact Inmar Inc. at 855-589-1869 or email rxrecalls@inmar.com.
This recall highlights the importance of accurate labeling in pharmaceuticals, particularly for medications like Clonazepam, where dosage precision is critical. The FDA and Endo Inc. have reiterated their commitment to patient safety and are working to address the issue swiftly.
For further updates and details about the recall, visit the FDA’s official website or contact your healthcare provider.
