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
D-1119-2017
Product summary
- Event
- Event 77869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,308 bottles
- Official record key
drug-enforcement:D-1119-2017
Official wording
Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Code information: Item# 370010, Lot: 20351701
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination