FDA recall D-1120-2017

The Harvard Drug Group · Class II · drug

Product

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85

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-1120-2017