To avoid the risk of severe infection, the Food and Drug Administration is advising consumers and health care providers not to use liquid drug or dietary supplements made by PharmaTech LLC of Davie, Fla.
The agency said that these products — labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands — are potentially contaminated with the bacteria Burkholderia cepacia (B. cepacia).
The PharmaTech drugs and dietary supplements include stool softeners, liquid vitamin D drops and liquid multivitamins marketed for infants and children.
“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 in a statement. “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 poses the greatest threat to hospitalized patients, critically ill patients and people with weakened immune systems and chronic lung diseases, according to the Centers for Disease Control and Prevention. The infection can spread from person to person by direct contact and is often resistant to antibiotics.
Distributors have voluntarily recalled these products, the FDA said.
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