SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, agreed to plead guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility. The resolution included a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act for $600 million. The drugs, manufactured at the plant between 2001and 2005, included Kytril, Bactroban, Paxil CR and Avandamet. The government alleged that SB Pharmco’s manufacturing operations failed to ensure that Kytril and Bactroban were free of microorganism contaminants; that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split, causing the potential distribution of tablets that did not have any therapeutic effect; that Avandamet tablets manufactured by SB Pharmco did not always have the Food and Drug Administration (FDA)-approved mix of active ingredients; and that SB Pharmco’s facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.