The FDA is alerting healthcare professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan.
The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
Burkholderia cepacia is the name for a group or “complex” of bacteria that can be found in soil and water. The bacteria are often resistant to common antibiotics. Burkholderia cepacia poses little medical risk to healthy people; however, it is a known cause of infections in hospitalized patients. People with certain health conditions, like weakened immune systems or chronic lung diseases (particularly cystic fibrosis), may be more susceptible to infections with Burkholderia cepacia, according to Outbreak News Today.
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In addition, FDA 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. FDA and the Centers for Disease Control and Prevention continue 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 with a Rugby label in one pint (473 mL) bottles. The FDA joins the CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.
In June, a multi-state outbreak of Burkholderia cepacia infections started. These infections have occurred primarily in ventilated patients without cystic fibrosis and who are being treated in intensive care units.
Rugby Laboratories is a leading provider of Over the Counter, vitamin, and nutritional supplement products. “With more than 40 years of history, Rugby® has a comprehensive portfolio of products designed to enhance the quality of life for our consumers while reducing the cost of purchasing their medications,” its website states.