FDA recall D-0226-2018

Pharmatech LLC · Class II · drug

Product

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; 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-0226-2018