Recall issued for PharmaTech liquids

Barsaba Taglieri
Agosto 13, 2017

Those infections include pneumonia.

Consumers, pharmacies, and healthcare facilities that have the recalled product should cease use and report any adverse events. A major concern is that infection by Burkholderia cepacia may be hard to treat, as the bacteria shows resistance to several antibiotics, the CDC warned.

"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. Through recent communication with FDA, Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech. Rugby then issued a voluntary recall of the PharmaTech-manufactured docusate sodium solutions.

The FDA reported several reports of B. cepacia infections in patients involving PharmaTech's Diocto Syrup and Diocto Liquid.

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

PharmaTech's liquid products, including drugs and dietary supplements used in infants and children, are distributed nationwide.

At the time, the FDA advised healthcare professionals and patients not to use liquid docusate products made at PharmaTech's Davie, Florida, facility.

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