The products may be contaminated with the bacteria Burkholderia cepacia
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PharmaTech of Davie, Florida, Rugby Laboratories, Major Pharmaceuticals and Leader Brandare 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 ofB. 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: 096295128611 | ALL LOTS |
| Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL, | UPC: 096295128628 | ALL LOTS |
| MAJOR PHARMACEUTICALS | |||
|---|---|---|---|
| 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 Supp | 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 |
| RUGBY LABORATORIES | |||
|---|---|---|---|
| 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 |
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).