August 4, 2017 — One year after all lots of Rugby® Diocto Liquid Stool Softener was recalled and 60 people were infected with B. cepacia, yet another recall has been issued.
Yesterday, Rugby Laboratories announced another recall for all lots of Diocto Liquid and Diocto Syrup (docusate sodium) laxatives made by PharmaTech, LLC.
The recall was issued after the FDA reported several cases of B. cepacia infections that may be linked to Diocto Liquid or Syrup.
The FDA says patients with lung diseases have the highest risk:
“If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.”
The previous recall was issued in August 2016 after two unopened bottles of Diocto Liquid tested positive for contamination with the bacteria B. cepacia.
Diocto Liquid and other docusate sodium laxatives were linked to 60 infections in 8 states. An investigation by the CDC and the FDA discovered a “direct link of contaminated water at PharmaTech to the multi-state B. cepacia outbreak.” Even so, the products returned by October 2016, less than a month after the first recall.
B. cepacia (or “Burkholderia Cepacia Complex”) is a type of bacteria that is commonly found in water and soil. It does not normally infect healthy people, but 42% of infections are deadly because it is naturally antibiotic-resistant. Infections with B. cepacia primarily occur in hospitalized patients who must use mechanical ventilators.
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