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# FDA Lab Findings Confirm Contaminated Docusate Sodium
- URL: https://www.fdaweb.com/fda-lab-findings-confirm-contaminated-docusate-sodium/
- Published: 2017-10-30T12:00:00.000Z
- Updated: 2026-09-14T22:58:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139996

FDA [says](https://www.fda.gov/Drugs/DrugSafety/ucm570672.htm?ref=fdaweb.com) its lab findings again link Rugby Diocto’s oral liquid docusate sodium to *Burkholderia cepacia.* The contamination was confirmed in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech (Davie, FL). The lot was collected by FDA in response to a 2017 multistate outbreak of *B. cepacia* complex bacterial infections that has affected at least eight patients in California and Maryland. Laboratory results from FDA and CDC indicate that PharmaTech’s docusate sodium product is the source of the infections. An [outbreak in 2016 ](https://www.fda.gov/Drugs/DrugSafety/ucm511527.htm?ref=fdaweb.com)included serious infections in 63 confirmed cases and 45 suspected cases in 12 states. These 2016 infections were also linked to contaminated product made by PharmaTech, as confirmed by CDC and FDA testing.