October 26, 2010: GlaxoSmithKline Will Plead Guilty and Pay $750 Million to Resolve Manufacturing Deficiencies at Puerto Rico Plant
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Boston, Mass. - The Justice Department announced today that SB Pharmco Puerto Rico, Inc., a subsidiary of GlaxoSmithKline, PLC (“GSK”), has agreed to plead guilty to charges relating to the manufacturing and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million.
The drugs, manufactured at the plant between 2001 and 2005, are Kytril, Bactroban, Paxil CR, and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug.