GlaxoSmithKline (GSK) received a warning letter from the Food and Drug Administration (FDA) regarding a potentially contaminated shipment of the company’s antidepressant Paxil and its failure to warn consumers of quality problems. The action stems from an October inspection of its plant in Ireland during which the FDA found several violations of good manufacturing practices.
GSK announced it will issue a Class III recall of Paxil made at the facility in question, meaning it is of less serious nature. The company says the issue is nothing consumers should be concerned about and that they believe there is no risk for injury.
However, according to the FDA warning letter, certain ingredients or equipment used to manufacture batches of the Paxil were contaminated with products from a pharmaceutical waste tank. The agency said that though GSK performed risk assessments and destroyed some batches of the drug, it did ship some lots that the FDA said were possibly contaminated.
The FDA also expressed concern about whether the facility is capable of reliably producing active drug ingredients that meet required specifications. “The process performance qualification studies … suggest that your equipment has not been sufficiently demonstrated to reliably perform its intended function,” the warning letter stated.
Paxil is an antidepressant from a class of widely prescribed drugs known as selective serotonin reuptake inhibitors, or SSRIs. Makers of SSRIs, including GSK, face thousands of personal injury lawsuits alleging the companies withheld information that using the drugs during pregnancy could cause serious birth defects.