Agencies alert health care providers to contaminated drug product

The Food and Drug Administration and Centers for Disease Control and Prevention recommend that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose, the FDA announced Saturday. PharmaTech LLC has voluntarily recalled all non-expired lots of a docusate sodium solution distributed by Rugby Laboratories of Livonia, MI, which has been contaminated with Burkholderia cepacia bacteria linked to an outbreak in five states. FDA said it has received several adverse event reports of infections in patients, some of which identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and CDC continue to investigate the extent of the issue to identify other potentially contaminated liquid docusate sodium products, and will provide additional information when it is available. FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to its MedWatch program.