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Attorney General Schneider and 37 Attorneys General Reach Settlement With GlaxoSmithKline and SB Pharmco over Substandard Pharmaceutical Manufacturing
June 23, 2011
AUGUSTA –Maine Attorney General William Schneider, along with 37 other attorneys general, reached a $40.75 million settlement with drug manufacturer GlaxoSmithKline, LLC (GSK) and SB Pharmco Puerto Rico, Inc. (SB) arising from allegations that the companies used substandard manufacturing processes at their plant in Cidra, Puerto Rico. The settlement includes $585,127 for Maine.
In a complaint filed today with the settlement agreement, Attorney General Schneider alleges that GSK and SB manufactured and distributed certain lots of Kytril (a sterile drug used to prevent nausea and vomiting caused by cancer chemotherapy and radiation treatment), Bactroban (an antibiotic ointment used to treat skin infections), Paxil CR (the controlled release formulation of the antidepressant drug, Paxil), and Avandamet (a combination Type II diabetes drug) that were adulterated because the manufacturing processes used to produce these lots were substandard.
GSK and SB are no longer manufacturing drugs at their Cidra facility, which has been closed since 2009.
“These manufacturing processes did not meet standards put in place to ensure that drugs available for consumers in the marketplace are safe and effective,” Attorney General Schneider said. “This settlement is part of our continuing effort to ensure that Maine consumers are protected from potential harm.”
As a result of the settlement, GSK and SB are prohibited from making deceptive claims regarding the manufacturing of all drugs formerly manufactured at the Cidra facility regardless of where these drugs are now produced. In addition, the companies cannot misrepresent the characteristics or cause the likelihood of confusion or of misunderstanding about the way in which they are manufactured.
Consumers should note that the adulterated batches have been recalled for many years and/or the products’ expiration dates have passed. If consumers have questions or concerns they should contact their health care provider. In addition to Maine, the Attorneys General of the following states and the District of Columbia participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Assistant Attorney General Carolyn A. Silsby of Attorney General Schneider’s Consumer Protection Division handled the case for Maine.
CONTACT: Brenda Kielty (207)626-8577