FDA MedWatch - Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia

"FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Sat, 16 Jul 2016 19:58:58 +0000

Title:     FDA MedWatch - Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia

Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia

AUDIENCE: Health Professional
ISSUE: The FDA 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.

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.
BACKGROUND: PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.
RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including link to the CDER Statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm511528.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm 
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