Brazil Suspends Sale of GSK's Paxil (Seroxat)

The National Health Surveillance Agency (ANVISA) have temporarily suspended the sale of GlaxoSmithKline's antidepressant Paxil.

ANVISA are the Brazilian drug regulatory agency who regulate the drugs Brazilian citizens are prescribed.

GlaxoSmithKline sent ANVISA correspondence stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues.

It's unknown where the contaminated batches originated from. The batches recalled are:

SH0040V (manufacture date, June 2013, and expiration date, June 2015),
RK0084V (manufacture date, August 2012, and expiration date, August 2014),
RJ0220V (manufacture date, July 2012, and expiration date, July 2014),
RJ0219V (manufacture date of July 2012, and expiration date, July 2014),
RC0113V (manufacture date, March 2012, and expiration date, March 2014)
RC0113V1 (manufacture date, March 2012, and expiration date March 2014).


Last month GSK Ireland were sent a warning letter from the FDA listing a series of violations regarding the state of their plant in Currabinny, Carrigaline, Cork. Paxil had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

Back in 2010 Glaxo plead guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.


Bob Fiddaman