The Paxil "spit pill" class action lawsuit alleges that Paxil "controlled release" (CR) tablets made between April 1, 2002 and March 4, 2005, contained a manufacturing defect that caused them to split apart. According to the complaint, Paxil CR tablets are intended to deliver the active ingredient over a period of time, and not all at once. When one splits apart, the outside coat breaks up and the drug is released while the tablets are still in the stomach. Patients end up with all of the active ingredient, without the benefits of the controlled-release, and received the entire dose at once. Or they get only the controlled-release ingredient without the active ingredients, the complaint says.
In March 2005, armed marshals with the Food and Drug Administration (FDA) raided GlaxoSmithKline plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections, the complaint charges.