Officials with the US Food and Drug Administration (FDA) are alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan, after the agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
In addition, FDA has received several adverse event reports of B. cepacia infections in 53 patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.
FDA officials said they join the Centers Disease Control and Prevention in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose. FDA and CDC will provide additional information when it is available.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.
1. FDA. Oral Liquid Docusate Sodium by PharmaTech : Recall – Contaminated with B. Cepacia. 2016; Safety alert.