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
D-1123-2017
Product summary
- Event
- Event 77869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,413 bottles
- Official record key
drug-enforcement:D-1123-2017
Official wording
Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Code information: Item# 370281 all lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination