Supplement maker on FDA blacklist after deadly bacteria found in water system

Enlarge / A scanning electron microscopic image of Burkholderia cepacia. (credit: CDC/ Janice Haney Carr)

The Food and Drug Administration advised consumers and healthcare providers Friday to avoid all liquid products made by PharmaTech LLC of Davie, Florida after 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. cepacia infections 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 PharmaTech's oral liquid docusate sodium, a stool softener. But suspicion of contamination crept to the company's 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.

PharmaTech described the recall as a "precautionary measure," but the FDA seemed to suggest that the problem required more urgency and issued an additional advisory.

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