Rugby Laboratories Recalls Diocto Liquid and Syrup

FDA says that Rugby Laboratories is recalling all lots of its Diocto Liquid and Diocto Syrup (docusate sodium solutions) manufactured by PharmaTech due to a risk of product contamination with Burkholderia cepacia. An agency MedWatch notice says FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients that may be linked to the two Diocto products.

Products containing B. cepacia, FDA says, could lead to infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some such infections could be serious or even life-threatening, the agency says.

The two products are used as stool softeners and are packaged in one pint bottles, according to the notice.

FDA says Rugby is notifying its distributors and customers by letter, and is arranging for return of all recalled products.