(Columbus, Ohio) – Ohio Attorney General Mike DeWine, along with 37 other state attorneys general, announced today a $40.75 million settlement, pending court approval, with pharmaceutical companies GlaxoSmithKline, LLC (GSK) and SB Pharmco Puerto Rico, Inc. (SB Pharmco) to resolve concerns about their alleged substandard manufacturing processes.
In a complaint filed today, Attorney General DeWine alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed batches of certain prescription drugs from a facility in Cidra, Puerto Rico from 2001 to 2004. The manufacturing processes used to produce the batches were substandard.
“We do not believe that these drugs pose any current risk to consumers, but this settlement emphasizes the continued importance of safety in the production of pharmaceutical drugs,” Attorney General DeWine said. “Companies must take appropriate precautions to ensure that consumers’ health and safety are never compromised.”
The affected drugs include certain lots of Kytril (a sterile drug used to prevent nausea and vomiting caused by cancer chemotherapy and radiation therapy), Bactroban (an antibiotic ointment used to treat skin infections), Paxil CR (the controlled release formulation of the popular antidepressant drug, Paxil), and Avandamet (a combination Type II diabetes drug).
GSK and SB Pharmco no longer manufacture drugs at their Cidra facility, which has been closed since 2009. Additionally, there is no current cause for concern regarding the drugs covered by this agreement because all affected batches have been recalled for many years, and the drugs’ expiration dates have passed. Consumers who have concerns should contact their health care providers.
The settlement prohibits GSK and SB Pharmco from making false, misleading, or deceptive claims regarding the manufacturing of all drugs formerly manufactured at the Cidra facility, regardless of where the drugs are produced now. In addition, the companies must not misrepresent those drugs’ characteristics, or cause likelihood of confusion or misunderstanding about the way they are manufactured.
GSK and SB Pharmco agree to pay $40.75 million to the participating states. Ohio’s share is $1.38 million, which will go to the Consumer Protection Enforcement Fund to support the office’s consumer protection efforts.
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, Maine, 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.
View the complaint
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Eve Mueller 614-466-3840
Mark Moretti 614-466-3840