Drug Manufacturer to Pay $2.25 Million to Settle Controlled Substances Act Allegations

NEWARK, N.J. – A pharmaceutical manufacturer agreed to pay $2.25 million to resolve allegations that it violated the Controlled Substances Act (CSA), U.S. Attorney Philip Sellinger announced today.

The manufacturer, Novel Laboratories Inc. (Novel), a subsidiary of Lupin Inc., also reached an administrative resolution with the Drug Enforcement Administration (DEA) by entering into a memorandum of agreement (MOA). 

“Pharmaceutical companies are not exempt from their regulatory responsibilities especially when dealing with controlled substances and the dangerous effects they have when misused,” Special Agent in Charge Cheryl Ortiz of the Drug Enforcement Administration’s New Jersey Field Division said. “This settlement reflects DEA’s commitment to making sure measures are in place to safeguard the community and hold DEA registrants accountable. I commend our Diversion Investigators for bringing this matter to a resolution”

According to documents filed in this case and the contentions of the United States contained in the settlement agreement:

From Jan. 1, 2019, to Aug. 31, 2021, Novel committed CSA violations involving its failure to account for approximately 3.1 kg oxycodone, 7.7 kg hydrocodone, and 30 kg Temazepam. DEA discovered these violations during on-site inspections of Novel beginning in the summer of 2021. The MOA requires Novel to improve its operations and remain in compliance with the law, and will remain in effect for three years.  

U.S. Attorney Sellinger credited diversion investigators of DEA, under the direction of Special Agent in Charge Cheryl Ortiz in Newark, with the investigation leading to the settlement agreement and MOA. 

The government is represented by Assistant U.S. Attorney Jordann R. Conaboy of the U.S. Attorney’s Opioid Abuse Prevention and Enforcement Unit in Newark.

The claims settled by the agreement are allegations only, and there has been no determination of liability.