Enlarge / A scanning electron microscopic image of Burkholderia cepacia.
The Food and Drug Administration advised consumers and healthcare providers Friday to avoid all liquid products made by PharmaTech LLC of Davie, Floridaafter finding dangerous Burkholderia cepacia bacteria in the water system used to manufacture its products. Those products include liquid drugs and dietary supplements labeled under Rugby Laboratories, Major Pharmaceuticals, and Leader Brands.
An outbreak of B. cepaciainfections affecting at least 60 people in eight states led the FDA and Centers for Disease Control and Prevention to PharmaTech. Late last year, the agencies tracked the source to more than 10 lots of PharmaTechs oral liquid docusate sodium, a stool softener. But suspicion of contamination crept to the companys other products, and this month PharmaTech issued a voluntary nationwide recall of its other liquid products, such as its liquid vitamin D drops and liquid multivitamins that are marketed for infants and children.
B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems, FDA Commissioner Scott Gottlieb said in a statement. These products were distributed nationwide to retailers, health care facilities, pharmacies and sold onlinemaking it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products.
A representative for PharmaTech reached by Ars declined to comment beyondthe recall announcement. The announcement includes a full list of products affected with images.
Burkholderia cepacia poses little risk to healthy people, the CDC notes. But it can be deadly in people with weakened immune systems or other conditions, such as cystic fibrosis. Infections can cause a range of symptomsfrom little to none or to severe respiratory distressand spread from person-to-person or through the environment. The bacteria is known to lurk in health care settings and is often found to be resistant to many common antibiotics.
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Supplement maker on FDA blacklist after deadly bacteria found in water system - Ars Technica
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