Sábado, 19 Agosto, 2017

FDA Recalls PharmaTech Liquid Products for B. cepacia Contamination Risk

Screen shot of FDA recall Screen shot of FDA recall
Danilo Martir | 13 Agosto, 2017, 14:58

According to the Food and Drug Administration, the products were distributed to wholesale and retail facilities, including hospitals and pharmacies.

Investigators also detected B. cepacia in the water system used to manufacture the product.

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These products, which include various drugs and dietary supplements intended for use in infants and children, have been linked to a PharmaTech-manufactured product connected to severe adverse event reports of B. cepacia infections in patients. After being alerted to the issue by FDA, Rugby Laboratories issued a voluntary recall on August 3, 2017 of Diocto Syrup and Diocto Liquid (docusate sodium solutions).

However, determining which products were manufactured by PharmaTech could prove hard "because these liquid products are not labeled with a PharmaTech label", the safety alert states.

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"I think a key concern is that FDA knows there is a problem with PharmaTech - but they don't quite have the list of all the companies that repackage PharmaTech products", Erin Fox, director of drug information at University of Utah Health Care, was quoted as saying in an article published in Regulatory Affairs Professionals Society. An FDA investigation traced the source of infection back to 10 lots of oral liquid docusate sodium manufactured by PharmaTech.

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