BOSTON, Oct. 26 (UPI) -- A subsidiary of drug giant GlaxoSmithKline pleaded guilty to quality lapses and will pay $750 million in fines, the U.S. Justice Department said Tuesday.
The subsidiary, SP Pharmco Puerto Rico Inc., was charged with selling two products, anti-nausea treatment Kytril and anti-infection ointment Bactroban, without guaranteeing they were free of contamination, the department said.
The manufacturing plant in Cidra, Puerto Rico, that produced the medicines is already closed, Justice said.
The plant also produced antidepressant Paxil CR and diabetes treatment Avandamet.
In a statement, the department said Paxil CR, the controlled release version of the medicine, was prone to splitting. The problem was deemed a "critical defect … (that) caused the potential distribution of tablets that did not have any therapeutic effect and tablets that did not contain any controlled release mechanism."
There were also problems with Avandamet, a tablet that was found to have uneven quality, with "too much or too little of the ingredient with the therapeutic effect."
The infractions took place from 2001 to 2005. In the settlement, the firm agreed to pay a $150 million criminal fine and $600 million to cover civil charges, the department said.
