The FDA has warned of potential contamination of a number of brands of drugs and dietary supplements manufactured by PharmaTech that have been voluntarily recalled by Rugby Labs, Major Pharmaceuticals and Leader Brands.
The regulatory agency said the liquid drugs and dietary supplement products produced by the Davie, Florida-based manufacturer could be potentially contaminated with the bacteria Burkholderia cepacia, which could cause severe patient infection.
The products that have been recalled include liquid docusate sodium drugs (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,” FDA Commissioner Scott Gottlieb, M.D., said 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.”
The Leader products that have been recalled are Liquid Multivitamin Supplement for Infants and Toddlers along with Liquid Vitamin D Supplement for Breastfed Infants.
Major Pharmaceutical branded products recalled include: Certa-Vite Liquid, Poly-Vita Drops, Poly-Vita Drops with Iron, Ferrous Drops Iron Supplement, D-Vita Drops, Tri-Vita Drops and Senna Syrup.
Rugby Labs branded products recalled include: C Liquid, Diocto Liquid, Ferrous Sulfate Elixir, Fer Iron Liquid, Senexon Liquid, Diocto Syrup, Aller Chlor Syrup, Calcionate Syrup, Cerovite Liquid, D3 400iu Liquid, Poly-Vitamin Liquid, Tri-Vitamin Liquid and Poly-Vitamin with Iron Liquid.