Some liquid drug or dietary supplement products marketed for infants manufactured by a Florida company may be contaminated and the U.S. Food and Drug Administration is advising consumers not to use them.
Liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, in South Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands have potential for contamination with Burkholderia cepacia (B. cepacia), according to a release from the FDA.
The bacteria contamination could risk a severe infection, and the FDA recommended stopping use and throwing out the items immediately.
The distributors already voluntarily recalled several of their products.
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The products, marketed for infants and children, include liquid stool softeners and various other dietary supplements, according to the FDA. The Center for Disease Control’s lab testing of the liquid detected a strain of the bacteria linked to reported patient infections.
The bacteria poses a “serious threat” to infants and children, as well as hospitalized patients, critically ill patients and those with weakened immune systems and lung diseases, according to the FDA release.
Symptoms of B. cepacia infections can vary from none at all to serious respiratory infections. The infection can spread though direct contact, according to the FDA. The infection is also often resistant to common antibiotics.
In 2016, the FDA advised health care professionals and patients not to use some products made at PharmaTech’s Davie facility after the products were implicated in CDC’s public health investigation into a multistate outbreak of B. cepacia infections, according to the release.
To report issues or quality concerns with the drugs and dietary supplements produce, complete and submit the report online at www.fda.gov/medwatch/report.htm; or download and complete the form, then fax it to 1-800-FDA-0178.
- 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
- 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
- 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
Provided by the FDA