In a follow-up to the multistate outbreak of Burkholderia cepacia linked to oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida, the Food and Drug Administration (FDA) reported this week that the investigation, in addition to detecting the bactertium in more than 10 lots of oral liquid docusate sodium, it also revealed 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.
Through Aug 10, the Centers for Disease Control and Prevention (CDC) has confirmed 60 cases from 8 states.
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.
Another B. cepacia outbreak linked to Nurse Assist saline flush is also being investigated.
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