GSK Recalls Paxil After FDA Warning Letter

April 3, 2014 — GlaxoSmithKline, the manufacturer of Paxil (paroxetine) antidepressants, has recalled certain batches because the active ingredient may have been tainted.

The recall was issued after the U.S. Food and Drug Administration (FDA) sent GSK a warning letter on March 18. The FDA said GSK did not fully investigate a list of problems inspectors found after visiting a manufacturing facility in Cork, Ireland in October 2013.

According to the FDA investigation, certain drug ingredients were contaminated with material from the plant’s pharmaceutical waste tank, which contained active pharmaceutical drugs, intermediates, and solvents. The FDA says GSK became aware of the problem in January 2012 and completed a risk-assessment in April 2013. However, GSK continued to sell potentially contaminated batches of Paxil after becoming aware of the problem.

GSK says there was no risk of harm to patients taking Paxil. The FDA says:

“We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact.”

The FDA threatened to withhold approval for any new drugs manufactured by GSK. The FDA could also embargo shipments of drugs from the facility in Ireland into the United States. This could potentially disrupt the supply — a company spokesperson told Reuters that “Cork is the main site for manufacturing the API (paroxetine). We do buy some from a third party, but Cork is the main site where we produce it.”