Regulatory Focus™ > News Articles > FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

Posted 12 October 2016 | By Zachary Brennan 

FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia, in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.  

PharmaTech in August voluntarily recalled all of its liquid drug formulations made at the Davie, Florida facility after being linked to the outbreak. The recall impacted products distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion and Virtus, including eight lots of Senna syrup (see photo) and all lots of Diocto Liquid (docusate sodium), a stool softener, distributed by Rugby Laboratories after the company received reports that the drug was contaminated with B. cepacia.

So far, the US Centers for Disease Control and Prevention (CDC) says it has confirmed 60 cases of B. cepacia infection in eight states. PharmaTech is the only company linked to the outbreak, an updated notice from Wednesday said, following US Food and Drug Administration (FDA) inspections of other oral liquid docusate sodium manufacturers.

The investigation into PharmaTech also detected B. cepacia in its water system.

“Laboratory evidence from FDA and CDC supports PharmaTech as the source of this outbreak,” FDA said Wednesday. “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.”

FDA also said that health care professionals can resume normal use of oral liquid docusate sodium not manufactured by PharmaTech and that it “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.” 

The agency added that it will continue to monitor adverse event reports for B. cepacia and that it “encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program.”  

FDA Notice


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