Paxil CR and Avandamet, FDA Seizes Product
U.S. Marshals Seize Lots of GlaxoSmithKline's Paxil CR and Avandamet Tablets Because of Continuing Good Manufacturing Practice Violations
In a response to ongoing concerns about manufacturing quality, the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and Type II Diabetes (Avandamet), failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity.
"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."