FDA recall D-0225-2018

Product

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL

Reason for recall

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

Distribution

MI

Key facts

Status

Terminated

Initiation date

2017-08-16

Report date

2018-01-24

Termination date

2023-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0225-2018