http://www.fda.gov/Drugs/DrugSafety/ucm511527.

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FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections
Update [10/12/2016]: FDA and CDC find direct link of contaminated water at
PharmaTech to the multistate B. cepacia outbreak
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, FDAs 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.
FDA will continue to monitor adverse event reports for B. cepacia related to
oral liquid docusate sodium. FDA also encourages health care professionals
and patients to report adverse events or quality problems experienced with
the use of oral liquid docusate sodium products to FDAs MedWatch Adverse
Event
.