Batches of the drugs Paxil CR and Avandamet United States, were seized by marshals at manufacturing and distribution plants in Tennessee and Puerto Rico after federal officials said the manufacturer failed to correct violations of production safety standards.
The drugs were seized at GlaxoSmithKline plants, one in Knoxville and two in Puerto Rico, on orders from the Department of Justice and the United States Food and Drug Administration. Paxil CR is a controlled-release antidepressant and Avandamet a diabetes drug .The F.D.A. had told the manufacturer in letters and warnings issued over the last three years, that problems their inspectors found with the drugs' production had to be corrected.
Although GlaxoSmithKline voluntarily recalled some of the affected lots, it failed to recall all affected products, forcing the agency to seek warrants from the United States District Courts for the seizure of the drugs.Drug manufacturers will not be allowed to ignore our high public health standards for drug manufacturing,said John M. Taylor, the F.D.A.'s associate commissioner for regulatory affairs.
Officials said they knew of no harm to any consumers as a result of the violations, and does not believe these products pose a significant health hazard to consumers.There was concern that GSK's violation of manufacturing standards could have resulted in the production of poor quality drug products with a potential risk to consumers.