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

Accepted submission by exec at 2017-08-15 03:47:12

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FeedSource: [ArsTechnica]

Time: 2017-08-14 15:28:28 UTC

Original URL: [] using UTF-8 encoding.

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

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

Arthur T Knackerbracket has found the following story []:

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.

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 online—making 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 beyond the recall announcement []. The announcement includes a full list of products affected with images.

-- submitted from IRC

Original Submission