- The Food and Drug Administration on Wednesday warned against the use of liquid products manufactured by PharmaTech, LLC at its Davie, Florida facility due to contamination with Burkholderia cepacia and the potential for infection.
- Earlier this month, Rugby Laboratories voluntarily recalled two liquid docustate products that were manufactured by PharmaTech.
- Burkholderia cepacia identifies a group of gram-negative bacteria that can cause pneumonia in patients with weakened immune systems or chronic lung diseases. Usually, such bacteria are resistant to commonly used antibiotics, according to the Centers for Disease Control and Prevention.
Last year, the FDA warned healthcare professionals and patients to not use liquid docustate products manufactured at the same Davie facility after an investigation by the CDC. A separate investigation by the FDA of a multi-state outbreak in 2016 identified B. cepacia in more than 10 lots of docustate sodium produced by Pharmatech, Wednesday's notice said.
The FDA wasn't able to identify other companies distributing PharmaTech products besides Rugby.
Companies purchasing liquid products from PharmaTech should quarantine any material received and contact the FDA's local pharmaceutical recall coordinator.
In May, the FDA issued a warning to pharmaceutical developers urging makers of water-based drugs to create and maintain protocols to prevent contamination from microorganisms like B. cepacia.