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Mallinckrodt pays $35m to settle alleged oxy reporting and production breaches

12 Juillet 2017

WASHINGTON | laboratories Mallinckrodt Pharmaceuticals will pay a fine of $ 35 million to be honored, and not be reported to the authorities, orders very important the drug is highly addictive Oxycodone, contributing to the crisis of opiate addiction in the United States.

According to federal authorities, Mallinckrodt failed to report suspicious orders for drugs that have been a part of the current opioid epidemic in MI and across the nation.

U.S. Attorney General Jeff Sessions said the settlement will send a message to other drugmakers that the Justice Department will seek to hold them accountable for their actions amid a national opioid addiction epidemic.

From 2008 to 2011, the government alleged Mallinckrodt supplied increasingly excessive quantities of oxycodone pills without notifying the DEA of the suspicious orders. Distributors provide information on the downstream customer purchases to obtain the discount.

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The government also alleged that Mallinckrodt violated record keeping requirements at its manufacturing facility in upstate NY. Accurate reconciliation of records at the manufacturing stage is a critical first step in ensuring that controlled substances are accounted for properly through the supply chain.

The U.S. Attorney's office says Mallinckrodt Pharmaceuticals, which is one of the largest manufacturers of narcotic painkiller oxycodone, will pay the fine to settle allegations that it violated the Controlled Substances Act including poor record keeping at its NY plant.

In reaching this resolution, the company denies government allegations that it violated applicable laws in connection with its suspicious order monitoring program, and the settlement contains no admission of liability for civil penalties for relevant conduct.

Mallinckrodt previously announced an agreement-in-principle to resolve the investigations in April.

Mallinckrodt pays $35m to settle alleged oxy reporting and production breaches