The FDA has warned consumers and professionals not to use 22 liquid drug and dietary supplement products made by a Florida company due to potential contamination with the bacteria Burkholderia cepacia and the risk for severe infection.
The products were manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals, and Leader Brands. The products range from stool softeners to liquid multivitamins marketed for infants and children. PharmaTech was implicated in a B. cepacia outbreak in 2016.
“B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems,” said FDA Commissioner Scott Gottlieb, MD. “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.”
According to the Centers for Disease Control and Prevention (CDC), B. cepacia poses the greatest threat to hospitalized patients, critically ill patients, and people with health problems such as weakened immune systems and chronic lung diseases. The symptoms of B. cepacia infections vary widely from none at all to serious respiratory infections. It can spread from person to person by direct contact and is often resistant to common antibiotics.
The companies voluntarily recalled all lots of the following products:
The FDA said CDC’s laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia linked to recent patient infections.
In 2016, FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at PharmaTech’s Davie facility after it was implicated in CDC’s public health investigation. These products were labeled and distributed by multiple companies, including Rugby. An FDA investigation associated with a 2016 multistate outbreak identified B. cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B. cepacia in the water system used to manufacture the product.