Diocto Liquid Stool Softener Recalled After Infection Outbreak

July 22, 2016 — The FDA and CDC are warning about a multi-state infection outbreak linked to a common over-the-counter liquid stool softener and a recall has been issued.

As of July 18, the CDC has confirmed 49 infections in five states among patients who were given liquid docusate sodium.

Even more case are currently under investigation. They have occurred primarily in patients on ventilators who do not have cystic fibrosis and are being treated in intensive care units.

PharmaTech LLC recalled Rugby® Diocto Liquid. It was sold nationwide and sold in a 1-pint (437 mL) bottle. An unopened bottle was found to be contaminated with B. cepacia.

Infections have been reported in patients who were given products made by other manufacturers. The FDA is warning doctors and patients not to use any liquid docusate stool softeners for any purpose.

The infections were caused by Burkholderia cepacia complex (also known as “B. cepacia complex”), a bacteria found in soil and water that is resistant to many common antibiotics.

Burkholderia cepacia

According to the CDC, the symptoms of B. cepacia infection vary widely, ranging from no symptoms at all to serious respiratory infections.

The risk of a life-threatening infection is highest for patients with weak immune systems, especially patients with chronic lung conditions like cystic fibrosis. Transmission occurs through person-to-person contact, contaminated medical devices, dirty surfaces, and exposure to B. cepacia in the environment.

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