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.

Rugby drugsThe 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.