• Subscribe to the AG's RSS Feed
  • Join the AG's FaceBook
  • Follow the AG on Twitter
  • View the AG's YouTube Channel
  • View the AG's Tumblr Page

Attorney General Kamala D. Harris and 37 Other Attorneys General Announce $40.75 Million Settlement over Allegations of Substandard Drug Manufacturing Processes

Friday, June 24, 2011
Contact: (415) 703-5837

SACRAMENTO --- Attorney General Kamala D. Harris and 37 other attorneys general announced a $40.75 million settlement with GlaxoSmithKline, LLC and SB Pharmco Puerto Rico, Inc. for alleged substandard drug manufacturing processes.

The settlement resolves allegations that GlaxoSmithKline and its subsidiary in Puerto Rico engaged in unfair and deceptive practices when they manufactured and distributed certain lots of drugs, which were adulterated because the manufacturing processes used to produce them were substandard.

“Consumers shouldn’t need to wonder if the drugs prescribed by their doctors are safe,” said Attorney General Harris. “This settlement resolves an unacceptable and potentially dangerous practice of GlaxoSmithKline and underscores my commitment to protecting the health and well-being of Californians.”

The drugs include: 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 form of Paxil, the popular antidepressant drug; and, Avandamet, a combination Type II diabetes drug.

GlaxoSmithKline and SB Pharmco no longer manufacture drugs at the facility in Puerto Rico, which closed in 2009. Consumers should be aware that there is no current cause for concern regarding the drugs covered by this agreement because the adulterated batches have been recalled for many years and/or the products’ expiration dates have passed. If consumers do have concerns, they should contact their health care provider.

As part of the settlement, GlaxoSmithKline and SB Pharmco agreed not to make false, misleading or deceptive claims regarding the manufacturing of all drugs formerly manufactured at the Puerto Rico facility – regardless of where these drugs are now produced. In addition, the companies must not misrepresent the characteristics of those drugs, or describe them in ways likely to cause confusion or misunderstanding about the way in which they are manufactured.

Illinois Attorney General Lisa Madigan and Oregon Attorney General John Kroger led the investigation into GlaxoSmithKline and SB Pharmco’s manufacturing practices.

States joining California, Illinois, Oregon and the District of Columbia in today’s settlement include Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

Supervising Deputy Attorney General Daniel Olivas and Deputy Attorney General Judith Fiorentini handled the case for Attorney General Harris’ Consumer Law section. California will receive more than $3.3 million from the settlement, the largest share among the states.

Copies of the complaint and settlement are attached to the online version of this release at ag.ca.gov.

###

# # #
AttachmentSize
Complaint1.19 MB
Stipulation4.75 MB
Final Judgement2.28 MB

Search News Releases

Subscriptions

Megan's Law

California Registered Sex Offender Database

Search Now

Megan's Law information is also available in these languages:

Site Navigation

Translate Website

  • Google™ Translation Disclaimer

This Google™ translation feature is provided for informational purposes only.

The Office of the Attorney General is unable to guarantee the accuracy of this translation and is therefore not liable for any inaccurate information resulting from the translation application tool.

Please consult with a translator for accuracy if you are relying on the translation or are using this site for official business.

If you have any questions please contact:Bilingual Services Program at (916) 324-5482

A copy of this disclaimer can also be found on our Disclaimer page.

Select a Language Below / Seleccione el Idioma Abajo

Close this box or use the [ X ]