General Neurology

Endo Recalls Clonazepam ODT Due to Carton Label Displaying Incorrect Strength

Diana Ernst, RPh
|
Publish Date
The blister strips inside the carton reflect the correct strength of 0.25mg.

A packaging error has prompted the recall of 1 lot of Endo’s Clonazepam Orally Disintegrating Tablets.

The product is being recalled because the incorrect strength of 0.125mg is appearing on the carton labels. The blister strips inside the carton reflect the correct strength of 0.25mg. 

Clonazepam Orally Disintegrating Tablets are indicated for use alone or as an adjunct in the treatment of Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. The benzodiazepine is also approved for treating panic disorder. 

Patients administered a 2-fold dose of clonazepam may be at increased risk for sedation, dizziness, ataxia, and confusion. Significant respiratory depression may also occur in patients with comorbidities such as pulmonary disease, or those taking concomitant medications that cause respiratory depression.

The recalled products are packaged in cartons of 60 tablets with NDC code 49884-306-02 and were distributed nationwide. The impacted units include:

  • Clonazepam Orally Disintegrating Tablets, USP 0.25mg, Lot# 550147301, expiration date August 2026.
  • Clonazepam Orally Disintegrating Tablets, USP 0.125mg, Lot# 550147301, expiration date August 2026.

At this time, there have been no reports of adverse reactions related to this recall. Additional information can be obtained by calling 877-890-0765 or via email at [email protected].

Adverse reactions or quality issues should be reported to the FDA’s MedWatch program.

This article originally appeared on MPR