Clinicians and patients should not use any liquid product manufactured by Pharma Tech LLC and distributed by Rugby Laboratories because of Burkholderia cepacia contamination and the potential for severe patient infection, the US Food and Drug Administration (FDA) advised today in a safety communication.
On August 3, Rugby Laboratories, of Livonia, Michigan, announced a voluntary recall of two oral liquid docusate products — Diocto Liquid and Diocto Syrup — manufactured by PharmaTech, of Davie, Florida.
"Additional liquid drug products manufactured by PharmaTech might also be affected. Such products might have been labeled and distributed by Rugby and other companies. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator," the FDA advised.
The agency acknowledges that it might be tough to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. Healthcare facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, should check with their supplier to determine who manufactured the product, the FDA said.
According to the FDA, laboratory testing of PharmaTech's oral liquid docusate, conducted by the Centers for Disease Control and Prevention (CDC), found a strain of B cepacia, which has been linked to recent infections in patients.
In 2016, the CDC and the FDA advised against using any liquid docusate drug products.
An investigation into a 2016 multistate outbreak identified B cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B cepacia in the water system used to manufacture the product, the FDA said.
This year, the agency said it has received reports of "several adverse events" related to oral liquid docusate sodium products.
Healthcare professionals are encouraged to report problems related to these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.