FDA warned consumers and health care professionals not to use a certain brand of drugs and dietary supplements that are contaminated.
FDA warned consumers and healthcare professionals not to use a certain brand of drugs and dietary supplements that are contaminated.
Any liquid drug or dietary supplement manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands may be contaminated with the bacteria Burkholderia cepacia (B. cepacia). They include liquid docusate sodium (stool softeners), as well as various dietary supplements including 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, MD, in a statement from FDA. “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 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, and the illness spread from person-to-person by direct contact. It is often resistant to common antibiotics.
Consumers, pharmacies and health care facilities should immediately stop using and dispensing all liquid drug and dietary supplement products manufactured by PharmaTech and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, FDA said.
The distributors voluntarily recalled the following products: the Leader brand of Liquid Multivitamin Supplement for Infants and Toddlers; the Leader brand of Liquid Vitamin D Supplement for Breastfed Infants; Certa-Vite Liquid 236ML from Major Pharmaceuticals; Poly-Vita Drops from Major; Poly-Vita Drops W/Iron from Major; Major’s Ferrous Drops Iron Supplement; Major’s D-Vita Drops; Major’s Tri-Vita Drops; Major’s Senna Syrup; Rugby Pharmaceuticals’ C Liquid, Rugby Diocto Liquid; Rugby Ferrous Sulfate Elixir; Rugby Fer Iron Liquid; Rugby Senexon Liquid; Rugby Diocto Syrup; Rugby Aller Chlor Syrup; Rugby Calcionate Syrup; Rugby Cerovite Liquid; Rugby D3 400iu Liquid; Rugby Poly-Vitamin Liquid; Rugby Tri-Vitamin Liquid; and Rugby Poly-Vitamin W/Iron Liquid.