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Violation Tracker Individual Record

Company: Endo Health Solutions Inc.
Current Parent Company: Endo International
Penalty: $1,536,000,000
Year: 2024
Date: May 3, 2024
Offense Group: safety-related offenses
Primary Offense: drug or medical equipment safety violation
Mega-Scandal: Opioid Crisis
Violation Description: Endo Health Solutions Inc. (EHSI) was ordered to pay $1.086 billion in criminal fines and an additional $450 million in criminal forfeiture--the second-largest set of criminal financial penalties ever levied against a pharmaceutical company--for violations of the Federal Food, Drug and Cosmetic Act related to the distribution of the opioid medication Opana ER with INTAC. EHSI pleaded guilty on April 18 to one misdemeanor count of introducing misbranded drugs into interstate commerce. In pleading guilty, EHSI admitted that from April 2012 through May 2013, certain EHSI sales representatives marketed Opana ER to prescribers by touting the drug's purported abuse deterrence, tamper resistance and/or crush resistance, despite a lack of clinical data supporting those claims.
Level of Government: federal
Action Type: agency action
Agency: Justice Department Civil Division
Civil or Criminal Case: criminal
HQ Country of Current Parent: Ireland
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: pharmaceuticals
Specific Industry of Current Parent: pharmaceuticals
Source of Data: (click here)
Archived Source: (click here)
Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.