FDA and CDC find direct link of contaminated water at PharmaTech to the multistate B. cepacia outbreak - Drug Information Update

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An FDA investigation associated with a multistate outbreak has identified the bacteria, Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida.  The investigation also detected B. cepacia in the water system used to manufacture the product. These products were manufactured by PharmaTech and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

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.

For more information, please visit: FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections.