Endo Broadens Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Possible Mislabeling of Product Carton Strength

Summary

Company Announcement

Endo, Inc. (OTCQX: NDOI) has declared an expansion of its previous voluntary recall involving Clonazepam Orally Disintegrating Tablets, USP (C-IV). This action is prompted by potential mislabeling of product cartons indicating improper strength.

Endo’s investigation reveals that certain lots of Clonazepam may include cartons that are incorrectly labeled regarding their strength and National Drug Code (NDC), due to a misstep by a third-party packager. However, the inner blister strips and tablets correctly display the strength for each lot.

The following table presents the newly included product lots in the voluntary recall along with their product description and NDC numbers.

Risk Statement:
Individuals who mistakenly take a higher dose of clonazepam may be at heightened risk for side effects such as significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There exists the potential for serious, possibly fatal, respiratory depression, especially for those with pulmonary issues, those nearing maximum prescribed doses, or those using other medications that may compound respiratory depression.

No reports of adverse events relating to this recall have been received to date by Endo.

Clonazepam Orally Disintegrating Tablets serve as a treatment option for Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, and panic disorder.

Package Identification:
This product is available in cartons of 60 tablets organized into 10 blister strips, with each strip containing 6 tablets. The packaging prominently displays the product name, strength, lot number, expiration details, and NDC number, alongside the legacy branding of Par Pharmaceutical, the prior marketer before acquisition by Endo.

Action Required:
The recalled product lots were shipped to various retail pharmacies across the country through wholesale distributors.

Endo is providing written notifications to retailers and wholesale accounts that received the impacted product lots and is facilitating the return process via Inmar, Inc.

Any distributors or retailers possessing the recalled product lot must cease distribution and return the product to the seller or reach out to Inmar via the provided telephone number.

Consumers with unused prescribed cartons of Clonazepam Orally Disintegrating Tablets that match the mentioned lot numbers are encouraged to halt usage.

Patients who took an incorrect dose instead of the prescribed amount should consult with a healthcare professional.

For inquiries about this recall, consumers can contact Inmar at 855-589-1869 (Monday to Friday, from 9 a.m. to 5 p.m. ET) or via email at rxrecalls@inmar.com.

Further details on Clonazepam Orally Disintegrating Tablets, USP, including the complete Prescribing Information and BOXED WARNING, are accessible at DailyMed – CLONAZEPAM tablet, orally disintegrating (nih.gov).

Any adverse reactions or quality concerns related to this product lot can be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program.

This recall is conducted with the FDA’s awareness.

About Endo
Endo is a versatile pharmaceutical entity committed to transforming insights into therapies that enhance lives. Our dedicated team strives to create and provide vital medication options. Together, we focus on empowering those we serve to achieve their best life. To learn more, visit www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This announcement encompasses forward-looking statements pertaining to recalls, mislabeling, potential adverse events, and regulatory actions. These statements, which may include terms like “believes,” “anticipates,” “may,” and others, reflect current views and expectations but carry inherent risks and uncertainties. Actual results may diverge markedly due to various factors, including those linked to the recall and any future incidents. Endo holds no obligation to update any forward-looking statements unless mandated by applicable securities laws.