Mallinckrodt Pays $35 Million Settlement for Inadequate Record-Keeping and Reporting

Mallinckrodt agreed to pay $35 million in a settlement for record-keeping errors and failure to report suspicious opioid orders.

The Department of Justice claimed the drugmaker lacked adequate record-keeping at its upstate New York manufacturing facility, creating discrepancies between batch records and actual number of tablets manufactured.

The settlement, the largest of its kind, also resolves claims that the company did not meet obligations to report suspicious orders of controlled substances to the Drug Enforcement Administration.