Following contamination with Burkholderia cepacia, a bacteria linked to an outbreak in five US states
The US FDA is alerting healthcare professionals that PharmaTech LLC, a contract development and manufacturing organisation (CDMO) located in Davie, Florida, US, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan.
The US regulator confirmed that the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
The FDA said it has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech.
The FDA and the Centers for Disease Control and Prevention are continuing to investigate the extent of this issue to identify other potentially contaminated liquid docusate sodium products.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby Laboratories with a Rugby label in one pint (473ml) bottles.
The FDA and CDC recommend that clinicians do not use any liquid docusate sodium product as a stool softener or for any other medical purpose. Additional information will be provided when it is available, they said.
Healthcare professionals and patients should report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.