GlaxoSmithKline has agreed to pay $750 million and plead guilty to settle a criminal charge from a U.S. government investigation related to the manufacture of defective pills, including the antidepressant Paxil, at its plant in Cidra, Puerto Rico between 2001 and 2005. U.S. authorities found that some tablets could split apart or had inappropriate amounts of active ingredient. After attempting to resolve the manufacturing issues at the Cidra facility, it was finally closed in 2009.
SB Pharmco, a unit of GSK, agreed to plead guilty to a criminal felony for releasing adulterated drugs into commerce, accounting for $150 million of the settlement. Other adulterated drugs cited in the settlement were Kytril anti-nausea medication, Bactroban anti-infective and Avandamet for diabetes.
The investigation was initiated by a suit filed by a former employee who, according to the Justice Department, is now entitled to $96 million from the settlement under a federal whistleblower law
GSK said in a statement it regrets that it operated the Cidra facility in a manner that was inconsistent with cGMP requirements and with GSK's commitment to manufacturing quality.