On July 11, 2017, the United States Department of Justice (DOJ) announced it had finalized a settlement with Mallinckrodt plc, a manufacturer of generic opioid products, over the manufacturer’s failure to report signs of opioid diversion. Mallinckrodt will pay $35 million to settle allegations that it violated certain provisions of the Controlled Substances Act (CSA) that are subject to civil penalties. In entering the settlement, the company admitted no fault or liability for civil penalties; the $35 million settlement resolves all potential claims.
Mallinckrodt will also improve its manufacturing records reconciliation to prevent discrepancies between the actual number of . . .