Search Results for PharmaTech

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FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs By Michael Mezher - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination.

Categories: News, US, FDA, Drugs, Labeling, Manufacturing

Tags: PharmaTech, Burkholderia cepacia, B. cepacia, Recall

FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak By Zachary Brennan - Published 12 October 2016

An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia, in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.

Categories: News, US, FDA, Business and Leadership, Compliance, Crisis management, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: bacterial outbreak, CDC, PharmaTech, US drug manufacturing

Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak By Michael Mezher - Published 10 August 2016

Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak.

Categories: News, US, FDA, Drugs, Medical writing, Product withdrawl and retirement, Quality

Tags: Contract manufacturing organization, PharmaTech, Burkholderia cepacia, B. cepacia, Docusate sodium, Recall