SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Headlines > Regulatory & Safety

Read more breaking news

 

 

US FDA warns against PharmaTech LLC-made meds over B.cepacia risk

By Gareth MacDonald+

10-Aug-2017
Last updated on 10-Aug-2017 at 12:20 GMT2017-08-10T12:20:15Z

iStock/10174593_258
iStock/10174593_258

The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.

The US regulator issued the warning on Tuesday , citing Michigan–based Rugby Laboratories’ withdrawal of two products - Diocto Liquid and Diocto Syrup – that had been made on its behalf by PharmaTech.

It said “Centers for Disease Control and Prevention laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia, bacteria linked to recent patient infections. Therefore, FDA recommends health care professionals and patients not use PharmaTech’s liquid drug products.”

In addition, the agency warned companies that have bought products from the Florida, US-based contractor to “immediately quarantine” the medicines.

Recalls

Burkholdia cepacia has been a concern in the US for several years.

Last year  the US Centres for Disease Control (CDC) reported a surge in infections in several States.

The FDA later  linked the outbreak to contaminated constipation remedies made by PharmaTech LLC .

PharmaTech recalled  products made at its facility in Davie, Florida last summer.

The FDA also investigated Laxachem Organics Pvt. Ltd, an Indian active pharmaceutical ingredient supplier  (API) that makes docusate sodium USP, the ingredient in the recalled products.

However, the agency later concluded  Laxachem had not supplied PharmaTech and was not the source of the bacterial contamination.

In October , a separate outbreak of Burkholderia cepacia infections was linked to contaminated prefilled saline flush syringes manufactured by Nurse Assist at its facility in Haltom City, Texas.

The syringes were recalled  later that month.

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...