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# PharmaTech Source of Burkholder Cepacia Outbreak: FDA
- URL: https://www.fdaweb.com/pharmatech-source-of-burkholder-cepacia-outbreak-fda/
- Published: 2016-10-12T12:00:00.000Z
- Updated: 2026-09-14T21:38:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137065

FDA says it has identified more than 10 lots of oral liquid docusate sodium manufactured by PharmaTechm, Davie, FL, as the source of a multistate outbreak of *Burkholder* *cepacia*. An agency safety [update](http://www.fda.gov/Drugs/DrugSafety/ucm511527.htm?ref=fdaweb.com) says its investigation also detected *B. cepacia* in the water system used to manufacture the product. The drugs were distributed and labeled by six firms—Rugby, Major, Bayshore, Metron, Centurion, and Vitus—the notice says.

The agency says it inspected other oral liquid ducosate sodium manufacturers and collected samples of their products and did not find the bacteria associated with the outbreak in any of the other products tested. It also says that current laboratory results do not indicate the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the outbreak.

“Healthcare professionals may resume normal use of oral liquid ducosate sodium not manufactured by PharmaTech,” the notice says. “FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products such as ducosate sodium to ensure low levels of microorganisms and the absence of those that may cause infection.”