FDA Announcement: Voluntary Recall of Certain Liquid Docusate Products, CDC/FDA Continue to Recommend Not Using Any Type of Liquid Docusate

Lisa Volk in Clinical & Quality

[7/16/16] U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. FDA and CDC continue to recommend that clinicians and patients not use any liquid docusate sodium product as a stool softener or for any other medical purpose. See below for further information:

From: Katherine Turner (CDC/OID/NCEZID)

Colleagues:

We are asking for your assistance with sharing the following notification to inform health departments, clinicians, pharmacists and patients. This information is also linked from the CDC outbreak site: https://www.cdc.gov/hai/outbreaks/b-cepacia/index.html.

FDA has released a statement (below and linked) regarding a voluntary recall of certain liquid docusate products. The extent of this issue remains under investigation; therefore, both FDA and CDC continue to recommend that clinicians and patients not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

FDA Announcement:

[7/16/16] U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.

PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.

In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.

Patient safety is our top priority. FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

FDA and CDC will provide additional information when it is available.

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
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.

NYSHFA CONTACT:

Lisa Volk, RN, B.P.S., LNHA
Director, Clinical & Quality Services
518-462-4800 15