Diocto Liquid Recalled Due to Burkholderia Cepacia Contamination

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PharmTech LLC is voluntarily recalling all lots of Diocto Liquid, which is a docusate sodium solution distributed by Rugby Laboratories.

Due to contamination concerns, PharmTech LLC is voluntarily recalling all lots of Diocto Liquid, which is a docusate sodium solution distributed by Rugby Laboratories.

The FDA discovered that the solution is contaminated with Burkholderia cepacia, which has led to an outbreak in 5 states.

The FDA has received numerous other adverse event reports of Burkholderia cepacia infections in patients, but not all of them come from the products manufactured by PharmaTech. Regardless, the FDA is working with the CDC to investigate all potentially contaminated products.

“Patient safety is our top priority,” the FDA wrote in a statement. “FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.”

The product, which was distributed nationwide, comes in a 1-pint (437 mL) bottle with a Rugby label.

Health care professionals are being encouraged to report any adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Burkholderia cepacia infection symptoms vary on a patient-to-patient basis. Some individuals may show no symptoms, while others may exhibit signs of a serious respiratory infection. Burkholderia cepacia can also be resistant to many common antibiotics. Infection can be spread through person-to-person contact, as well as contact with contaminated surfaces.

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