FDA recall D-0022-2017

The Harvard Drug Group · Class I · drug

Product

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

Reason for recall

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-07-15
Report date: 2016-10-19
Termination date: 2017-03-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2017