The settlement addresses Government allegations of discrepancies between the actual number of tablets manufactured at the site in Hobart and the number of tablets Mallinckrodt reported in its batch records.
The payment also covers the allegation that UK-headquartered Mallinckrodt did not set up a system to detect and report suspicious orders by some pharmacies and clinics – those that were unusual in frequency and size – to the US Drug Enforcement Administration (DEA).
According to the US Government “In addition to the significant monetary penalty, this settlement includes a groundbreaking parallel agreement with the DEA, as a result of which the company will analyze data it collects on orders from customers down the supply chain to identify suspicious sales.”
It added that the “DEA’s Memorandum of Agreement with Mallinckrodt also sets forth specific procedures it will undertake to ensure the accuracy of batch records and protect loss of raw product in the manufacturing process.”
Mallinckrodt denied violating federal laws and admitted no liability in the settlement.
Michael-Bryant Hicks, General Counsel, Mallinckrodtsaid: “While Mallinckrodt disagreed with the US government's allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers."
The firm declined to comment when contacted by in-Pharmatechnologist.com.