Endo Broadens Recall of Clonazepam Orally Disintegrating Tablets Due to Potential Carton Strength Mislabeling

**Endo’s Expansion on Clonazepam Tablet Recall Over Potential Packaging Mislabeling**

Endo, Inc., a multifaceted pharmaceutical corporation, has communicated that its subsidiary, Endo USA, Inc., will be broadening the initial voluntary recall of clonazepam orally disintegrating tablets, USP (C-IV). This decision follows the detection of potential mislabeling concerning product carton strength.

Ongoing investigations by Endo have pointed towards a scenario where certain clonazepam product lots may exhibit cartons printed with inaccurate strength and National Drug Code (NDC) numbers due to packaging oversights by a third-party. However, the blister strips and tablets inside include the correct strength particulars matching their designated lot.

### Potential Risks:
If individuals, including both children and adults, accidentally consume a clonazepam dose higher than prescribed, it may result in serious effects such as pronounced drowsiness, confusion, dizziness, slowed reflexes, lack of muscle function, and muscle weakness. Patients, particularly those with respiratory conditions, those on high dosage schedules, or those concurrently taking multiple medications with similar effects, reasonable likelihood exists for severe, or even life-threatening, respiratory depression.

As of now, Endo has not documented any adverse events directly linked to this recall.

### Product Use:
The clonazepam orally disintegrating tablets serve in the treatment of Lennoz-Gastaut syndrome (a variant of petit mal epilepsy), akinetic and myoclonic seizures, as well as panic disorder.

### Packaging Details:
The tablets come in cartons with 60 tablets separated into 10 blister strips, each containing 6 tablets. The packaging retains the Par Pharmaceutical legacy branding, a former marketer of clonazepam before Endo acquired the product.

### Procedural Advice:
The affected lots have been distributed from wholesale suppliers to retail pharmacies nationwide.

Endo is issuing formal notifications to involved wholesale accounts and retailers and facilitating the return process of all existing inventories through Inmar, Inc.

Retailers and distributors with relevant lot numbers are instructed to cease distribution and sales immediately and initiate returns to the original purchase location or contact Inmar.

Consumers possessing recalled clonazepam disintegrating tablets with the aforementioned lot numbers should stop usage immediately.

Should a patient mistakenly ingest an incorrect dosage, consulting a healthcare provider is advisable.

For inquiries related to this product recall, consumers can reach Inmar at 855-589-1869 during standard business hours (Monday through Friday, 9 a.m. to 5 p.m. ET) or via email at [email protected].

**About Endo:**
Endo continues to excel as a diverse pharmaceutical entity, committed to transforming knowledge into life-altering therapies. Its dedicated team strives to innovate and deliver these vital medicines.