The Food and Drug Administration is warning consumers and healthcare providers not to use any liquid drug or dietary supplements due to potential contamination.
The drug and dietary supplement products are manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, which may be contaminated with the bacteria Burkholderia cepacia, or B. cepacia.
The products in the warning include liquid docusate sodium drugs or stool softeners, and dietary supplements including liquid vitamin D drops and liquid multivitamins for infants and children.
“B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems,” FDA Commissioner Dr. Scott Gottlieb, said in a press release. “These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online — making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products.”
B. cepacia symptoms can vary from none to serious respiratory infections, is spread by direct contact and is often resistant to antibiotics. Hospitalized patients, critically ill patients and people with weakened immune systems are the most vulnerable to the infection.
In 2016, the FDA warned patients and healthcare providers to not use liquid docusate drug products manufactured at PharmaTech’s Davie, Fla., facility because the products were part of the CDC’s public health investigation into a multi-state outbreak of B. cepacia.