GlaxoSmithKline has agreed to pay $750m to the US authorities in relation to the sale of contaminated baby ointment and an ineffective antidepressant manufactured at its Cidra plant in Puerto Rico.
According to papers filed in federal court in Boston, the products were mis-identified as a result of product mix-up. The medicines included the antidepressant Paxil CR and the diabetes treatment Avandamet.
In a statement, the Justice Department said that the settlement includes a criminal fine and forfeiture totaling $150m and a $600m civil settlement under the False Claims Act and related state claims.
Reportedly, $96m will be paid to GSK former quality assurance manager Cheryl Eckard, who warned of a series of manufacturing lapses at the Puerto Rico facility.
The UK-based pharmaceutical ginat had worked hard to redress the issues before shutting down the Puerto Rico plant in 2009 due to decreasing demand for the drugs it makes.
GSK senior vice-president and Global Litigation head PD Villarreal said they regret that they had operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice requirements and with the company's commitment to manufacturing quality.