PharmaTech Recalls Contaminated Docusate Sodium Solution

PharmaTech LLC (Davie, FL) is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium stool-softening solution distributed by Rugby Laboratories, Livonia, MI. The agency has confirmed the product has been contaminated with Burkholderia cepacia, a bacterium linked to infection outbreaks in five states. Symptoms include pneumonia, septicemia and localized infection in various organs, according to the Merck Manual.

In addition, FDA says it has received several adverse event reports of B. cepacia infections in 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,” a recall notice says.