Popular anxiety drug, Clonazepam, recalled nationwide for ‘possibly life-threatening’ error

The FDA recently announced a recall of the anxiety-reducing drug Clonazepam after a potentially “life-threatening” label mix-up was discovered. The recall was issued by Endo Inc., who voluntarily recalled 16 lots of Clonazepam Orally Disintegrating Tablets due to a labeling error that resulted in incorrect strength and National Drug Code (NDC) being printed on the packaging.

The mislabeling of the drug could have serious consequences for children and adults prescribed Clonazepam, as it may lead to significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. The FDA warned that there is a risk of “life-threatening” respiratory depression, especially for patients with pulmonary disease, those taking maximal dosages, and individuals using other medications that could exacerbate respiratory depression.

Fortunately, as of November 21, no adverse effects have been reported as a result of the recall. The company stated that the labeling error was made by a third-party packager. The recalled products were distributed to pharmacies nationwide in cartons containing 60 tablets packed into 10 blister strips of six tablets.

Individuals who have unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets with the specified lot numbers are advised to discontinue use of the product. If a patient accidentally took an incorrect dose of the medication, they should consult a physician immediately. Consumers with questions about the recall can contact Inmar Inc., the company handling the recalls, by telephone at 855-589-1869 or by email at rxrecalls@inmar.com.

Clonazepam tablets are commonly used to treat seizures and panic disorder, as they work by helping to calm the nervous system. They belong to a class of medications called benzodiazepines, according to the Cleveland Clinic.

It is crucial for individuals who have been prescribed Clonazepam to check their medication and ensure that they have not received any of the recalled lots. The safety and well-being of patients are of utmost importance, and it is essential to follow the FDA’s guidelines in response to the recall to prevent any potential harm.