"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John M. Taylor, FDA Associate Commissioner for Regulatory Affairs. "Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner. American consumers deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products."

FDA is not aware of any harm to consumers by the products subject to this seizure and it does not believe that these products pose a significant health hazard to consumers. Consequently, FDA urges patients who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected. FDA has determined that neither product is medically necessary and that alternative products are available for consumer use.

The agency is concerned that GSK's violation of manufacturing standards may have resulted in the production of poor quality drug products that could potentially pose risks to consumers. Among the violations noted during FDA's latest inspection was the finding that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in this product.

GSK has voluntarily recalled some of the affected lots of Paxil CR and Avandamet; however, it has failed to recall all affected lots of these products. This failure on the part of GSK resulted in the seizures by federal authorities.