Officials with the U.S. Food and Drug Administration is 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. The agency confirmed the product has been contaminated with Burkholderia cepacia.
Through July 14, the Centers for Disease Control and Prevention (CDC) has confirmed 53 cases from 5 states.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.
In addition, FDA 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.
Burkholderia cepacia is the name for a group or “complex” of bacteria that can be found in soil and water. Burkholderia cepacia bacteria are often resistant to common antibiotics. Burkholderia cepacia poses little medical risk to healthy people; however, it is a known cause of infections in hospitalized patients. People with certain health conditions, like weakened immune systems or chronic lung diseases (particularly cystic fibrosis), may be more susceptible to infections with Burkholderia cepacia.