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:
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).
Keep an eye on your inbox, the lastest consumer news is on it's way!