Misbranding

Purdue Pharma Agrees to Pay $600 Million Fine for Misbranding Oxycontin

US-based Purdue Pharma, makers of painkiller OxyContin agreed to pay $600 million in fines and other payments to resolve the criminal charge of misbranding the product , one of the largest amounts ever paid by a drug company in such a case. Three of its current and former executives pleaded gu...

When Your Breakfast is Considered a 'Drug'

...at include product/drug claims, marketers and their agents should consider the broad definition of "labeling" under the Act and the ramifications of a misbranding claim. If you would like to continue to receive periodic updates on regulatory developments from the FDA and State and Federal authorities, pl...

Quest Diagnostics to Pay U.S. $302 Million to Resolve Allegations That a Subsidiary Sold Misbranded Test Kits

... Quest Subsidiary, Nichols Institute Diagnostics, Pleads Guilty to Felony misbranding WASHINGTON, April 15 /PRNewswire-USNewswire/ -- Quest Diagnostics Inc...day before U.S. District Judge Sterling Johnson Jr. in Brooklyn to a felony misbranding charge in violation of the Food, Drug and Cosmetic Act relating to NID's Ni...

US Drugmaker Slapped Huge Fine for Misleading Doctors Over Addictive Painkiller

...sales and also pleaded guilty to charges of playing down Oxycontins addictive and euphoric properties. Purdue pleaded guilty to a felony count of misbranding a drug with intent to defraud and mislead. Under the agreement, it will pay a $600 million settlement, including a criminal fine, restitution to ...

Raids By US Marshals Uncovers Cache’ Of Unapproved Drug

...Nutraceuticals L.L.C distributed the capsules. Sources have indicated that the seized capsules, which are supposedly in violation of new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act, include, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support. I...

Misbranding in Medical Technology

FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

... To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will...rd Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less sub...

Misbranding in Biological News

Dietary supplements manufacturers gain new tool to help ensure quality products

...al origin and their dosage forms. USPNF is considered an official compendium under the Federal Food, Drug, and Cosmetic Act (FDCA), with the FDCA food misbranding provisions applying to any dietary supplement product represented as conforming to compendial specifications (and such products being deemed misbrande...

Misbranding in Biological Technology

Quest Diagnostics Finalizes Previously Announced Settlement With Government Related to Test Kit Subsidiary Closed in 2006

...ment with the government. In addition, NID agreed to enter a guilty plea to misbranding and to pay a $40 million fine. The misbranding charge was based on claims by NID concerning performance of a test kit, whi...