FDA Finds Link Between Contaminated Water at Pharmatech and a Multi-State Outbreak of B. Cepacia

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.

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