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