Clonazepam tablets recalled over 'life-threatening' label mistake

(WJW) — A popular anxiety drug is being recalled over a 'life-threatening' label mistake.

In a recall alert for certain lots of Clonazepam Orally Disintegrating Tablets, the company that produces the tablets has said the medication is mislabeled with the incorrect strength on the carton. The mistake could lead to patients taking incorrect dosages, which could be "life-threatening" for some.

According to the Cleveland Clinic, Clonazepam tablets treat seizures and can also be used to treat panic disorder. 

Endo, Inc., the pharmaceutical company that issued the recall, said in a Nov. 18 press release that the recall was an expansion of a previously announced recall of the items of concern.

Endo, Inc. 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 said in the recall announcement that the blister strips and tablets inside the product pack reflect the correct strength for the lot.

As of earlier this week, the company said it had 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. If a patient inadvertently took an incorrect dose, they are advised to contact a doctor.

More information, including the lot numbers impacted by the recall, can be found in a notice published by the FDA.