FDA Recalls PharmaTech Liquid Products for B. cepacia Contamination Risk

Rugby Laboratories began recalling two PharmaTech oral liquid docusate products on August 3: Diocto Liquid and Diocto Syrup.

"I think a key concern is that FDA knows there is a problem with PharmaTech - but they don't quite have the list of all the companies that repackage PharmaTech products", Erin Fox, director of drug information at University of Utah Health Care, was quoted as saying in an article published in Regulatory Affairs Professionals Society. The bacteria involved is Burkholderia cepacia, or B. cepacia.

The regulatory agency previously had warned against using PharmaTech's oral liquid docusate, after the Centers for Disease Control and Prevention detected a strain of the bacteria in the product following a 2016 multistate outbreak of infections.

These products, which include various drugs and dietary supplements intended for use in infants and children, have been linked to a PharmaTech-manufactured product connected to severe adverse event reports of B. cepacia infections in patients.

At the time, the FDA advised healthcare professionals and patients not to use liquid docusate products made at PharmaTech's Davie, Florida, facility.

Three drug distributors on Thursday issued nationwide recalls for all liquid drugs manufactured by PharmaTech, an Athens, Ga. -based drugmaker.

Latest News