(WJW) – A popular anxiety drug is being recalled over a “life-threatening” label mistake.
In a recall alert for some lots of Clonazepam Orally Disintegrating Tablets the FDA states the medication is mislabeled with the incorrect strength on the carton and as a result, could be life-threatening for some patients.
According to the Cleveland Clinic, Clonazepam tablets treat seizures and can also be used to treat panic disorder.
In a press release dated Nov. 18, Endo, Inc. stated the company was expanding its previously announced voluntary recall of the items of concern.
The company released the following risk statement:
Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There is 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.
Endo, Inc.
The company said the labeling error was made by a third-party packager. Endo notes in the recall announcement that the blister strips and tablets inside the product pack reflects the correct strength for the lot.
So far, the company states they have not received any reports of adverse events associated with the recalled products which were distributed to retail pharmacies nationwide.
Patients are advised to stop using the recalled medication and if a patient inadvertently took an incorrect dose they are advised to contact a doctor.
Click here to view the lot numbers impacted by the recall.
