FDA Alert: Liquid Drug Products Contaminated with Burkholderia Cepacia

Officials with the FDA are warning health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to possible Burkholderia cepacia contamination, according to a safety alert issued by the FDA.

Rugby Laboratories, Livonia, Michigan, recently announced a voluntary recall of 2 such products — Diocto Liquid and Diocto Syrup, both oral liquid docusate products manufactured by PharmaTech. Such products may be distributed by other companies, as well. Because the products do not have PharmaTech labeling, pharmacies and health care facilities are urged to check with their suppliers to determine the manufacturer of their liquid drug products.

The advisory was issued after CDC laboratory testing of the oral liquid docusate detected a strain of B cepacia, bacteria linked to recent patient infections.

The FDA previously advised health care professionals and patients against use of liquid docusate drug products manufactured at PharmaTech’s Davie, Florida, facility after being implicated in the CDC’s public health investigation.

A 2016 investigation of a multistate outbreak of B cepacia revealed contamination in more than 10 lots of oral liquid docusate sodium manufactured by the company, which was linked to severe patient infections. The investigation also revealed B cepacia in the water system used to manufacture the product.

According to the safety alert, patients, pharmacies, and health care facilities are advised to immediately stop using and dispensing all liquid products manufactured by PharmaTech. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator.

Reference

Liquid drug products manufactured by PharmaTech and distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory — Not to use [FDA safety alert]. FDA’s website. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570674.htm. Accessed August 9, 2017.