FDA: Don’t use these liquid drug or dietary supplement products for infants

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.

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.

This story was originally published August 11, 2017 at 7:27 PM with the headline "FDA: Don’t use these liquid drug or dietary supplement products for infants."