PharmaTech LLC is recalling all unexpired lots of Diocto Liquid, a docusate sodium stool softener distributed by Rugby Laboratories after testing by the Food and Drug Administration (FDA) confirmed the solution was contaminated with Burkholderia cepacia, a bacteria linked to an outbreak of infections in patients in five states.
B. cepacia bacteria can cause potentially serious respiratory infections, especially in patients with cystic fibrosis. Docusate sodium is a stool softener that makes bowel movements softer and easier to pass. The solution is used to treat or prevent constipation and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.
The FDA has received several adverse event reports of B. cepacia infections in patients that in some cases identify liquid docusate sodium products manufactured by companies other than PharmaTech. The FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate the extent of this issue in order to identify other potentially contaminated docusate sodium products.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles. The CDC is recommending that health care professionals not use any liquid docusate sodium product as a stool softener or for any other medical purpose. Both the FDA and the CDC will provide additional information about this recall as more information becomes available.
Any adverse events related to PharmaTech liquid docusate sodium or docusate sodium from any other manufacturer should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.