A product for treating constipation produced by Florida-based CMO PharmaTech is being recalled after the FDA confirmed it was contaminated with Burkholderia cepacia, a bacterium linked to an outbreak in hospitals in 5 states. But the FDA says docusate sodium solution products from other manufacturers may also be contaminated with the bacterium, which has infected more than 50 people.
The outbreak was initially seen in ventilated patients without cystic fibrosis who were being treated in intensive care units but has since been tied to other patients, leading the Centers for Disease Control and Prevention to warn doctors over the weekend not to prescribe any liquid docusate sodium products.
PharmaTech, a CMO based in Davie, FL, near Fort Lauderdale, is recalling all unexpired lots of its Diocto Liquid product, which the FDA said is distributed nationwide by Livonia, MI-based Rugby Laboratories in one-pint bottles with a Rugby label. The company declined to comment today. In March, PharmaTech announced that its Florida manufacturing facility had successfully passed an FDA inspection.
So far, the CDC says it has confirmed 53 bacterial infections. It first started receiving reports of infections in ventilated cystic fibrosis patients in late June. It warned today that serious infections could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. The agency did not identify the 5 states from which it has received reports or the other products that might be tied to the infections.
The FDA has had to face this kind of situation with other drug products in recent years. In 2012, the now-defunct New England Compounding Center was responsible for a nationwide fungal meningitis outbreak that made hundreds sick and killed more than 60 people. That case led to changes in federal law and the FDA’s oversights of drug compounders. Earlier this month, New Jersey-based Pharmaceutical Innovations resolved both federal criminal and civil cases for distributing ultrasound gel that was contaminated with bacteria and was tied to infections of 16 patients in a Michigan hospital in 2012.