Feds blame multistate B. cepacia outbreak on PharmaTech plant's water system

FDA sign

After a months-long investigation, federal officials have nailed down the source of a Burkholderia cepacia outbreak that made its way into several states and infected dozens of patients.

In an update Thursday, the Centers for Disease Control and Prevention and the FDA said they had detected the B. cepacia bacteria in the water system at Florida-based CMO PharmaTech. The company had produced 10 contaminated lots of constipation drug docusate sodium before 6 distributors shipped the meds around the country. In total, 60 people in 8 states became infected.

The agencies cleared the drug's active ingredient as a potential source, allowing healthcare providers to resume use of docusate sodium from other manufacturers.

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The outbreak started in late June in ventilated cystic fibrosis patients. During the investigation, CDC officials said infections could be life-threatening in patients with compromised immune systems or lung conditions.

Back in July, PharmaTech recalled all lots of its Diocto Liquid after the FDA confirmed they had been contaminated. The company’s facility just passed an FDA inspection in March.

As the investigation unfolded last month, authorities announced they had placed India’s Laxachem on its import alert after the company refused to allow FDA officials to inspect its site. Among the APIs the company is believed to make is docusate sodium, officials said.

Back in 2012, federal officials had to wrestle a deadly outbreak that started at the now-defunct New England Compounding Center. And just this year, Pharmaceutical Innovations resolved federal criminal and civil cases for distributing contaminated ultrasound gel.

Related Articles:
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CMO expands drug recall over bacterial contamination concerns
CMO recalls constipation drug tied to bacterial infections reported in 5 states
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U.S. Marshals seize ultrasound gel containing dangerous levels of bacteria

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