Update August 25, 2017

CDC is collaborating with the Food and Drug Administration (FDA), state and local health departments, and healthcare facilities to investigate recent outbreak of Burkholderia cepacia infections associated with exposure to liquid docusate.

FDA has released a statement regarding a voluntary recallexternal icon of multiple brands of drugs and dietary supplements manufactured by PharmaTech LLC and distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories, regardless of manufacture/expiration date. These medications are used in inpatient and outpatient settings.

The recall is due to risk of product contamination with B.cepacia and the potential for human infection. PharmaTech liquid docusate products were also implicated in an outbreak of B. cepacia infections in 2016. CDC does not currently suspect that docusate products manufactured by other companies contain B. cepacia.

B. cepacia complex is an environmental pathogen. It can live on surfaces and in water. Infections may be transmitted through lapses in infection control, including indirect contact via environmental surfaces. Person-to-person transmission is possible but less common. B. cepacia complex bacteria can grow in aqueous environments, can exhibit resistance to preservatives, and can cause contamination of liquid medications or other liquid products. This has led to healthcare-associated outbreaks of B. cepacia complex. Healthcare facilities should consider implementing contact precautions in the setting of an ongoing outbreak of B. cepacia to reduce the risk of transmission. For additional information on B. cepacia please visit: Burkholderia cepacia in Healthcare Settings.

If you suspect patient infection(s) possibly associated with a medical product, we encourage you to alert your local or state health department and submit a voluntary report to MedWatch, the FDA Safety Information and Adverse Event Reporting programexternal icon.

The product recall notice and list of products can be found here: Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratoriesexternal icon.

FDA Press Release August 11, 2017: FDA warns of potential contamination in multiple brands of drugs, dietary supplementsexternal icon

FDA Alert August 8, 2017: FDA updates on 2017 Burkholderia cepacia contaminationexternal icon