FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections

A multistate outbreak of Burkholderia cepacia has caused investigations of the US FDA and CDC. These investigations identified Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida. Additinally B.cepacia was found in the water system which was used to manufacture the oral liquid docusate sodium. These products were manufactured by PharmaTech and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

Further the FDA stated:

"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.

Laboratory evidence from FDA and CDC supports PharmaTech as the source of this outbreak.

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.

Health care professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech.

FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products such as docusate sodium to ensure low levels of microorganisms and the absence of those that may cause infection. "

For health care professionals or patients who want to report further events or quality problems experienced with the use of oral liquid docusate sodium products can do this with the FDA’s MedWatch Adverse Event Reporting program.

For more information please see "Updates on Multistate Outbreak of Burkholderia cepacia Infections"

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