FDA: B. Cepacia Contamination Confirmed in Liquid Stool Softeners
The Food and Drug Administration (FDA) is alerting healthcare professionals that PharmaTech LLC is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution.
The product has been confirmed to be contaminated with the bacteria Burkholderia cepacia. As of July 14, 2016, this bacteria has been associated with an outbreak of 53 cases in five states. The FDA has further received adverse event reports of B. cepacia infections in patients associated with liquid docusate sodium manufactured by different companies.
Diocto Liquid, distributed by Rugby Laboratories, is supplied in 473mL (1 pint) bottles. At this time, the FDA and the Centers for Disease Control and Prevention (CDC) is continuing to recommend that clinicians do not use any liquid docusate sodium product for any medical purposes. The Agency and the CDC are continuing to investigate this issue to identify other potentially contaminated products.
For more information call (888) 463-6332 or visit FDA.gov.