Multiple Products From Florida Company Recalled Due to Bacteria Concerns

Products manufactured by PharmaTech were sold by three firms

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:

  • LEADER BRANDS: Liquid Multivitamin Supplement for Infants and Toddlers 50 mL; Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL
  • MAJOR PHARMACEUTICALS: Certa-Vite Liquid 236 mL; Poly-Vita Drops 50 mL; Poly-Vita Drops With Iron 50 mL; Ferrous Drops Iron Supplement 50 mL; D-Vita Drops 50 mL; Tri-Vita Drops  50 mL; Senna Syrup 237 mL
  • RUGBY LABORATORIES: C Liquid 500 mg 118 mL; Diocto Liquid 50 mg/5ml 473 mL; Ferrous Sulfate Elixir 473 mL; Fer Iron Liquid 50 mL 50 mL; Senexon Liquid 237 mL; Diocto Syrup 60 mg/15 mL 473 mL; Aller Chlor Syrup 120 mL; Calcionate Syrup 16 oz.; Cerovite Liquid 236 mL; D3 400 IU Liquid  50 mL; Poly-Vitamin Liquid 50 mL; Tri-Vitamin Liquid 50 mL; Poly-Vitamin With Iron Liquid 50 mL

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.

Sources: FDA; August 11, 2017; FDA; August 8, 2017