GlaxoSmithKline has said it will recall some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. But the U.K.-based drugmaker didn't decide to take the step until it was publicly chastised by the FDA about the problem in a warning letter.
The FDA posted the warning letter to its website Tuesday citing a GSK ($GSK) plant in Cork, Ireland, following a 5-day inspection last October. It criticized the drugmaker for releasing some products made with solvents contaminated from a "waste tank." It also lambasted the U.K. drugmaker for deciding that the issue did not warrant telling its customers and for determining there was no reason to believe the products were affected. "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 told the drugmaker.
The highly redacted letter does not identify the products or the contaminants but says one product was held after testing, suggesting problems, but another was shipped. In an emailed statement after news got out about the warning letter, the drugmaker said that the ingredient was paroxetine.
GSK said it had proposed recalling some batches of the antidepressants made with the suspect ingredient from wholesalers. But it also insisted the products were safe. "A medical assessment concluded that there is no risk of harm to patients by taking Paxil/Seroxat manufactured from the implicated batches of paroxetine API," the company said. It also said it is reviewing the FDA's concerns and would respond to them by the FDA deadline.
The API plant was part of SmithKline Beecham before its merger with Glaxo Wellcome in 2000 to form the current company. It makes a variety of products and last year, the drugmaker completed a €30 million ($40.6 million) expansion to manufacture Gantrez, the adhesive used in the company's Poligrip denture product.
- here's the warning letter