PhotoPharmaTech of Davie, Florida, Rugby Laboratories, Major Pharmaceuticals and Leader Brand are recalling various liquid drug or dietary supplement products.

The products may be contaminated with the bacteria Burkholderia cepacia, which poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems.

The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech-manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions).

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.

These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online

The following firms are recalling their products:

LEADER BRAND
Liquid Multivitamin Supplement for Infants and Toddlers 50 mL,UPC: 096295128611ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL,UPC: 096295128628ALL LOTS
MAJOR PHARMACEUTICALS
Certa-Vite Liquid236ML00904-5023-09ALL LOTS
Poly-Vita Drops50ML00904-5099-50ALL LOTS
Poly-Vita Drops W/Iron50ML00904-5100-50;ALL LOTS
Ferrous Drops Iron Supp50ML00904-6060-50ALL LOTS
D-Vita Drops50ML00904-6273-50ALL LOTS
Tri-Vita Drops50ML00904-6274-50ALL LOTS
Senna Syrup237ML00904-6289-09ALL LOTS
RUGBY LABORATORIES
C Liquid 500mg118ML00536-0160-97ALL LOTS
Diocto Liquid 50mg/5ml473ML00536-0590-85ALL LOTS
Ferrous Sulfate Elixir473ML00536-0650-85ALL LOTS
Fer Iron Liquid 50ML50ML00536-0710-80ALL LOTS
Senexon Liquid237ML00536-1000-59ALL LOTS
Diocto Syrup 60MG/15ML473ML00536-1001-85ALL LOTS
Aller Chlor Syrup120ML00536-1025-47ALL LOTS
Calcionate Syrup16OZ00536-2770-85ALL LOTS
Cerovite Liquid236ML00536-2790-59ALL LOTS
D3 400iu Liquid50ML00536-8400-80ALL LOTS
Poly-Vitamin Liquid50ML00536-8450-80ALL LOTS
Tri-Vitamin Liquid50ML00536-8501-80ALL LOTS
Poly-Vitamin W/Iron Liquid50ML00536-8530-80ALL LOTS

What to do

Consumers who purchased the recalled products should immediately stop using them.

Consumers with questions may contact Rugby Laboratories/Major Pharmaceuticals customer support at 1-800-645-2158, Monday through Friday 8 a.m. – 8 p.m. (EST).

Leader Customer Support may be reached at 1-800-200-6313 option #1 Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m (EST).

 


Share your Comments