The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.
The drug and dietary supplement products made by PharmaTech 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.
As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.
“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, M.D. “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.
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. These distributors voluntarily recalled the following products:
Liquid Multivitamin Supplement for Infants and Toddlers 50 mL, UPC: 096295128611 ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL, UPC: 096295128628 ALL LOTS
Certa-Vite Liquid 236ML 00904-5023-09 ALL LOTS
Poly-Vita Drops 50ML 00904-5099-50 ALL LOTS
Poly-Vita Drops W/Iron 50ML 00904-5100-50 ALL LOTS
Ferrous Drops Iron Supplement 50ML 00904-6060-50 ALL LOTS
D-Vita Drops 50ML 00904-6273-50 ALL LOTS
Tri-Vita Drops 50ML 00904-6274-50 ALL LOTS
Senna Syrup 237ML 00904-6289-09 ALL LOTS
C Liquid 500mg 118ML 00536-0160-97 ALL LOTS
Diocto Liquid 50mg/5ml 473ML 00536-0590-85 ALL LOTS
Ferrous Sulfate Elixir 473ML 00536-0650-85 ALL LOTS
Fer Iron Liquid 50ML 50ML 00536-0710-80 ALL LOTS
Senexon Liquid 237ML 00536-1000-59 ALL LOTS
Diocto Syrup 60MG/15ML 473ML 00536-1001-85 ALL LOTS
Aller Chlor Syrup 120ML 00536-1025-47 ALL LOTS
Calcionate Syrup 16OZ 00536-2770-85 ALL LOTS
Cerovite Liquid 236ML 00536-2790-59 ALL LOTS
D3 400iu Liquid 50ML 00536-8400-80 ALL LOTS
Poly-Vitamin Liquid 50ML 00536-8450-80 ALL LOTS
Tri-Vitamin Liquid 50ML 00536-8501-80 ALL LOTS
Poly-Vitamin W/Iron Liquid 50ML 00536-8530-80 ALL LOTS
Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 a.m. – 8 p.m. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m EST.