FDA advises health care professionals and patients not to use any liquid drug products manufactured by PharmaTech and distributed by Rugby Laboratories and possibly other companies
CDC lab testing detects product contamination, links products to patient infections
[8/8/2017] FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection.
Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products – Diocto Liquid and Diocto Syrup, both oral liquid docusate products – manufactured by PharmaTech.
Additional liquid drug products manufactured by PharmaTech might also be affected. Such products might have been labeled and distributed by Rugby and other companies. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator.
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.
Patients, pharmacies, and health care facilities should immediately stop using and dispensing all liquid products manufactured by PharmaTech. It might be difficult to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. FDA advises health care facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, to check with their supplier to determine the identity of the manufacturer.
Patients who are using liquid drug products and who have concerns should contact their health care professional.
In 2016, FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at PharmaTech’s Davie, Florida, facility after being implicated in CDC’s public health investigation. These products were labeled and distributed by multiple companies, including Rugby. An FDA investigation associated with a 2016 multistate outbreak identified B. cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B. cepacia in the water system used to manufacture the product.
FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products to ensure low levels of microorganisms and the absence of any that might cause infection (Click Here).
FDA has received in 2017 reports of several adverse events related to oral liquid docusate sodium products. FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
FDA will provide additional information when it is available.