FDA and CDC links B. cepacia outbreak to contamination at PharmaTech

12-Oct-2016 - Last updated on 13-Oct-2016 at 09:51 GMT

The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.

According to the Centers for Disease Control and Prevention (CDC) there is currently an outbreak of Burkholderia cepacia infections with 60 confirmed cases across eight states.

Laboratory evidence from both the CDC and the US Food and Drug Administration (FDA) shows PharmaTech LLC as the source of this outbreak, the government agencies announced yesterday.

They identified the bacteria in more than 10 lots of oral liquid docusate sodium made by the contract manufacturing organisation (CMO) at its facility in Davie, Florida.

“FDA also inspected other oral liquid docusate sodium manufacturers and collected samples of their products. The bacteria associated with this multistate outbreak has not been found in other oral liquid docusate sodium products FDA tested,” the FDA said.

“In addition, FDA’s current laboratory results do not indicate the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the B. cepacia outbreak.”

In August, PharmaTech recalled all liquid products produced at its manufacturing site since October 2015 due to a risk they had been contaminated with the bacteria.

These were being sold by six firms: Rugby, Major, Bayshore, Metron, Centurion, and Virtus.