(Adds company statement)
By Vrinda Manocha
April 1 The U.S. Food and Drug Administration
found that a drug ingredient manufactured at a GlaxoSmithKline
Plc plant in Ireland was contaminated and said the
company did not take sufficient action to resolve the problems.
GSK said the ingredient was paroxetine, used to make its
antidepressant drugs Paxil and Seroxat.
The company said it had proposed a recall of certain batches
of the drugs from wholesalers but there was no risk of harm to
patients taking these drugs.
In a warning letter dated March 18, the FDA said GSK did not
fully investigate a list of objectionable conditions the
regulator sent after its inspection of the plant at Cork in
Some batches of a drug or drugs using the contaminated
ingredient were later shipped, the FDA said, and GSK did not
notify its customers about the lapse.
The FDA said its investigator found that a certain drug
ingredient was contaminated with material from the plant's
pharmaceutical waste tank. (link.reuters.com/xah28v)
The FDA said it might withhold approval of any new drug
applications that list GSK as the manufacturer of their drug
ingredients until GSK corrected the issues.
The regulator said it also might refuse the import of drugs
manufactured at the Cork facility into the United States.
The Cork plant is the company's only drug ingredient
manufacturing facility in Ireland.
"Cork is the main site for manufacturing the API
(paroxetine), we do buy in some from a third party, but Cork is
the main site where we produce it," a company spokesman told
Over-the-counter medicines and oral care products are
manufactured at a plant in Dungarvan, while consumer products
are made at Sligo, both in Ireland.
GSK recorded sales of 285 million pounds ($474.11 million)
for Paxil and Seroxat in 2013, the spokesman said.
The investigator also raised concerns about the suitability
of the equipment used to manufacture the ingredients.
The news comes just days after GSK said it was recalling all
supplies of its over-the-counter weight-loss drug in the United
States and Puerto Rico, after concerns that bottles had been
The FDA has stepped up its efforts to ensure drug safety in
recent months, banning drugs and drug ingredients imported from
Indian manufacturers over quality concerns.
Ranbaxy Laboratories Ltd has been banned from
exporting drugs from its Indian plants to the United States. One
of Sun Pharmaceutical Industries Ltd's plants and some
of Wockhardt Ltd's plants have also been barred from
exporting to the United States.
($1 = 0.6011 British Pounds)
(Reporting by Vrinda Manocha in Bangalore; Editing by Maju
Samuel and Don Sebastian)