Endo USA, Inc., a subsidiary of the generic and specialty pharmaceutical company Endo, Inc., has broadened its recall of Clonazepam Orally Disintegrating Tablets (C-IV) as reported by the U.S. Food and Drug Administration (FDA). The issue involves drugs that have been mislabeled with incorrect strength details on their packaging.
The FDA highlighted that the packaging references Par Pharmaceutical, Inc., a legacy company that previously marketed clonazepam before it was acquired by Endo.
The recall now encompasses additional lots of these tablets, which are used both independently and as an adjunct treatment for Lennoz-Gastaut syndrome (a form of petit mal variant), as well as akinetic and myoclonic seizures. Additionally, clonazepam is used in the treatment of panic disorders.
The expanded recall specifically targets Clonazepam Orally Disintegrating Tablets with strengths of USP 0.125 mg, 0.25 mg, 1 mg, and 2 mg. These are packaged in cartons containing 60 tablets, with each carton housing 10 blister strips, each strip containing six tablets. Various lot codes and National Drug Code (NDC) numbers are involved.
The concern over mislabeling arises from packages of Clonazepam Orally Disintegrating Tablets, USP 2 mg, lot 550176501, which bear cartoning with product descriptions and NDC codes meant for Clonazepam Orally Disintegrating Tablets, USP 1 mg, 60 count.
The affected lots have been distributed nationwide by wholesale distributors to retail pharmacies.
In mid-July, the company previously recalled Clonazepam Orally Disintegrating Tablets, USP 0.25 mg, and USP 0.125 mg, both in 60-count cartons with lot 550147301 and an expiration date of August 2026, due to similar issues.
Endo's ongoing investigation suggests a possibility that the recalled Clonazepam product lots include some cartons printed with incorrect strength and NDC codes, attributed to an error by a third-party packaging entity. However, the blister strips and the tablets within the packaging accurately reflect the correct strength for each lot.
For patients, including children and adults, accidentally prescribed a two-fold overdose of clonazepam, there could be adverse reactions such as significant sedation, dizziness, ataxia, and confusion. Some individuals may experience severe, potentially life-threatening respiratory depression, particularly those with existing pulmonary conditions, those nearing maximal dosing prescriptions, and patients taking other drugs that potentially exacerbate respiratory depression.
However, to date, Endo has not received any reports of adverse events related to this recall.
Endo is requesting that distributors and retailers halt the distribution and dispensing of these products, and to return them to the place of purchase or contact Inmar Inc. Consumers are urged to cease using the recalled products immediately.
