Posted August 18, 2017

FDA Warns Consumers Not to Use Certain Liquid Multis, Vitamin D, and Other Supplements Due to Potential Bacterial Contamination

On August 11, 2017, the FDA advised the public 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, because they have the potential to be contaminated with Burkholderia cepacia.

Burkholderia cepacia is not thought to pose a health risk to healthy individuals. However, individuals with compromised immune systems or chronic lung conditions may be more susceptible to infection with Burkholderia cepacia, which can infect the upper airway. The bacterium is also resistant to a number of antibiotics and may be difficult to treat once an infection occurs. Burkholderia cepacia infections may be serious or even life-threatening in the at risk patient population.

The products that should be avoided include liquid docusate sodium drugs (stool softeners) and various dietary supplements including liquid vitamin D drops and liquid multivitamins marketed for infants and children.

The following products have been recalled by their distributors:

"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 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
"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
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.

Consumers and healthcare providers are also encouraged to report any adverse reactions to the FDA's MedWatch Adverse Event Reporting Program.

PharmaTech had issued a recall of 20 liquid vitamin supplements in August of 2016, also for possible Burkholderia cepacia contamination.

See related recalls and warnings:

Liquid Multis, Vitamin D & More Recalled Due to Potential Bacterial Contamination

Zicam Nasal Gel Recalled Due to Potential Bacterial Contamination

To read the FDA warning, use the link below.