FDA Warns: Don’t Use These Potentially Contaminated Liquid Supplements And Medications

The Food and Drug Administration is warning consumers and medical professionals not to use liquid supplements and medications made by Pharmatech, including some products marketed for use by babies and small children. These products — distributed under multiple brand names, including Rugby, Major, and Leader — may be contaminated with potentially dangerous bacteria.

An FDA recall currently applies only to certain products, but the agency is warning consumers against using any liquid products made by Pharmatech.

What’s happening here?

The Food and Drug Administration received reports of infection with Burkholderia cepacia that were potentially linked to a liquid version of docusate sodium, a stool softener sold under the Colace and Dulcolax brands.

Burkholderia cepacia is a common bacteria that is often antibiotic-resistant and can cause severe infections in people with weak immune systems or who have lung disease. It’s especially dangerous for people with cystic fibrosis.

B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems,” FDA Commissioner Scott Gottlieb said in a statement.

The recall

When the infections were first linked to the liquid laxatives, just the liquid docusate sodium products were recalled. The recall later expanded to all liquid medications made by Pharmatech, which are distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories.

The official recall includes the following products:

Leader Brand

• Liquid Multivitamin Supplement for Infants and Toddlers: 50 mL
• Liquid Vitamin D Supplement for Breastfed Infants 400 IU: 50 mL

Major Pharmaceuticals

• Certa-Vite Liquid: 236ML
• Poly-Vita Drops: 50ML
• Poly-Vita Drops W/Iron: 50ML
• Ferrous Drops Iron Supplement: 50ML
• D-Vita Drops: 50ML
• Tri-Vita Drops: 50ML
• Senna Syrup: 237ML

Rugby Laboratories

• C Liquid 500mg: 118ML
• Diocto Liquid 50mg/5ml: 473ML
• Ferrous Sulfate Elixir: 473ML
• Fer Iron Liquid: 50ML
• Senexon Liquid: 237ML
• Diocto Syrup 60MG/15ML: 473ML
• Aller Chlor Syrup: 120ML
• Calcionate Syrup: 16OZ
• Cerovite Liquid: 236ML
• D3 400iu Liquid: 50ML
• Poly-Vitamin Liquid: 50ML
• Tri-Vitamin Liquid: 50ML
• Poly-Vitamin W/Iron Liquid: 50ML

What to do

Patients, pharmacies, and health care providers have been warned not to use any liquid products from Pharmatech. If you have these medications at home, don’t use them: Contact the distributor or the pharmacy where you purchased them for a refund.

If you have questions about the products, call 800-645-2158 for products from Rugby Laboratories and Major Pharmaceuticals, and 800-200-6313 for Leader Brand.