FDA recall D-1119-2017

The Harvard Drug Group · Class II · drug

Product

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2017-08-02
Report date
2017-08-30
Termination date
2024-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1119-2017