Rugby Laboratories is voluntarily recalling all lots of Diocto Liquid and Diocto Syrup (docusate sodium) manufactured by PharmaTech LLC due to a risk of bacterial infections with B. cepacia.
Rugby issued the recall after the FDA told the company about several adverse event reports of B. cepacia infections in patients that may be linked to Diocto Liquid or Diocto Syrup made by PharmaTech.
The FDA limited its warning to high-risk patients, but said B. cepacia infections can be serious or even life-threatening:
If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.”
Diocto Liquid is a laxative that is primarily given to hospitalized patients who are recovering from a heart attack or a recent surgery, when straining to have a bowel movement might be harmful. It is also used in patients who need mechanical ventilators or intensive care.
Rugby previously recalled all lots of Diocto Liquid in August 2016 after 2 unopened bottles tested positive for B. cepacia. The CDC also confirmed 60 infections in 8 states among hospitalized patients who were given Diocto Liquid or other brands of liquid docusate sodium laxatives.
The FDA warned doctors not to give patients any brand of liquid docusate sodium laxatives for any purpose — but the products returned by October 2016, shortly after FDA investigators found a “direct link of contaminated water at PharmaTech to the multi-state B. cepacia outbreak.”
Burkholderia cepacia (or “B. cepacia complex”) is a bacteria that is found in soil and water. Infections have a 42% mortality-rate because it resists many antibiotics. B. cepacia mostly infects hospitalized patients who are already very sick, especially cystic fibrosis patients on ventilators.