MALVERN, Pennsylvania — Endo USA, Inc. has announced a voluntary nationwide recall of one lot of Clonazepam Orally Disintegrating Tablets due to a labeling error. The affected lot, number 550147301, is labeled as 0.125 mg on the product carton, while the actual tablets inside are 0.25 mg.
The recall, announced on July 16, 2024, affects Clonazepam Orally Disintegrating Tablets used to treat panic disorder and certain types of seizures. The error occurred at a third-party packaging facility, leading to a potential risk of patients taking a higher dose than intended. Taking a higher dose can cause significant side effects, including sedation, dizziness, and confusion, with a risk of serious respiratory depression, particularly in patients with existing respiratory issues or those on other medications that affect breathing.
The product was distributed nationwide to retail pharmacies. Endo USA is notifying wholesalers and retailers to arrange for the return of the affected products. Consumers are advised to check their medication and discontinue use if they have mislabeled tablets. They should contact their physician if they have taken the incorrect dose.
For questions, consumers can contact Inmar at 877-890-0765 or via email at [email protected]. Adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program online or by mail.
The FDA is aware of the recall, and there have been no reported adverse events related to this lot.
